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Job Title: Radiology Service Engineer Location: Cooperman Barnabas Medical Ctr Department Name: Imaging Services Req #: 0000217059 Status: Hourly Shift: Day Pay Range: $28.15 - $43.64 per hour Pay Transparency: The above reflects the anticipated hourly wage range for this position if hired to work in New Jersey. The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience. Reports to assigned work locations as required to meet organizational needs. RSE2 demonstrates confidence using tools and test equipment to perform preventative maintenance and service on radiological equipment. Ensures radiological equipment meets manufacture specifications and is safe for patient care. Demonstrates troubleshooting skills necessary to complete most repairs on multiple modalities. When necessary provides information to assisting engineers to minimize down time and loss of continuity of care. Aids team members and other clinical engineering staff both remotely and onsite as required. Documents all work performed in a timely fashion and participates in the radiology emergency on-call program. Staff assists management in meeting regulatory requirements and department/organizational goals. Performs other duties as assigned or required. Qualifications: Required: * • Minimum AAS degree in Biomedical Engineering, Electronics Engineering Technology or equivalent work/military experience on radiology equipment., • 3+ years of experience servicing radiology equipment on more than one vendor and/or modality, • Can demonstrate proficient use of hand tools, • Working knowledge of electricity/electronics, • Working knowledge of mechanical and electro-mechanical components, • Can demonstrate proficient use of electronic test equipment including oscilloscope, • Can complete most repairs without assistance, • Working knowledge of MS-Office and other computer applications, • Working knowledge of computers and networks, • Working knowledge of radiological safety procedures, • Multiple manufacture certifications, • Attentive to detail and excellent follow-up with customers., • Excellent customer service skills, • Ability to work under pressure, • Ability to attend vendor technical training regardless of method or location, • Valid NJ Driver’s License Scheduling Requirements: • Days to work- 8A-4P M-F, occassional Saturday, • Full-Time, • Working Location(s): Livingston, possible local travel to other RWJBH sites Essential Functions: • Conducts preventive maintenance inspections appropriate to level of job competence using appropriate productivity & quality measures., • Completes monthly assigned tasks within the specified timeframe prioritizing inspections of high risk over low risk equipment., • Recognizes unsafe conditions & notifies appropriate management team members to correct them., • Works collaboratively with senior technical staff to creates & enter PM procedures following manufacturer guidelines., • Effectively responds to service requests, competently troubleshoots & repairs medical equipment appropriate to job proficiency level using established productivity & quality measures, demonstrating good judgment on performing component vs. circuit board level repairs., • Demonstrates the need to maintain an adequate level of parts on hand as applicable, to assist in keeping downtime to an absolute minimum., • Timely and accurately documents all service requests and repairs in the biomedical equipment database., • Inspects new devices & equipment with competence appropriate to job proficiency level. This includes judgment on safety, compliance with codes, standards & ability to learn about the function/performance of new devices with speed & comprehension., • Secures all required device information for biomedical equipment database., • Demonstrates the need to have current service and operator manuals on hand for proper servicing of all types of medical equipment., • Assists Manager in maintaining and fulfilling the department/organizational regulatory requirements and goals., • Complies with system, hospital and departmental policies and procedures and objectives., • Reports witnessed violations that put patients, staff, department or facility in jeopardy to appropriate management personnel., • Demonstrates a thorough knowledge of shop safety including the use of electronic test equipment., • Assists Manager with responding to/correcting medical equipment recalls/device alerts from manufactures and/or F.D.A., • Participates in On Call duties after normal working hours. Must respond to a call within 15 minutes by telephone, and report to the facility within a maximum of one hour if required to be on site., • Ability to give technical instruction to users over the phone minimizing equipment downtime while providing the continuum in patient care, and organizational cost effectiveness.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview: The Staff Engineer, Design is primarily responsible for designing and developing new production equipment and tooling to support manufacturing needs, including cost reduction, ergonomic improvements, quality enhancements, and new product introductions. Following equipment deployment, the engineer supports validation activities and assists maintenance/manufacturing teams when validation or maintenance findings require design modifications. This role ensures that equipment designs are robust, well-documented, and compliant with applicable medical device regulations. Job Responsibilities and Essential Duties • Design and develop new production equipment, tooling, jigs, and fixtures that improve manufacturability, efficiency, ergonomics, and quality., • Create detailed SolidWorks CAD models, engineering drawings, and specifications for internal fabrication or external vendor manufacturing., • Lead equipment reviews and incorporate feedback from manufacturing engineering, maintenance, and production operators., • Work with external suppliers and fabrication shops to communicate design intent, resolve build issues, and verify component quality., • Ensure all equipment designs comply with internal engineering standards, safety requirements, and medical device regulations., • Support Manufacturing Engineering and Maintenance teams during equipment validation , installation, and troubleshooting., • Implement and document equipment design modifications based on validation outcomes or equipment performance issues., • Provide updated drawings, documentation, and bills of materials when equipment changes are made., • Assist in preparing capital expenditure documentation for new equipment, including engineering rationale, cost analysis, and recommendations., • Make informed engineering decisions based on analysis, testing, and validated data., • Work independently while collaborating with cross-functional teams. Minimum Requirements • Bachelor's degree in Engineering (Mechanical Engineering preferred) or related technical discipline., • 8+ years of experience in equipment or tooling design within a manufacturing environment (medical device preferred)., • Proficiency in SolidWorks including part/assembly modeling, and drafting., • Hands-on experience with prototype builds, mechanical troubleshooting, and equipment commissioning., • Strong understanding of mechanical systems, pneumatics, electromechanical integration, and manufacturing methods., • Ability to generate and revise engineering drawings, BOMs, and technical documentation., • Excellent communication, collaboration, and timemanagement skills. Required Knowledge, Skills and Abilities • Strong mechanical design and engineering analysis skills., • Understanding of validation concepts (IQ/OQ/PQ) in a regulated environment., • High proficiency in CAD and supporting engineering software (Excel, Word, PDM, etc.)., • Ability to communicate effectively with operators, technicians, engineers, vendors, and management., • Strong problem-solving skills with a focus on robust design solutions. Targeted salary range: $115,000- $140,000, depending upon experience and location +10% bonus target #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview As a Sr. Quality Engineer specializing in Quality Operations, you will be responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices. Job Responsibilities and Essential Duties • Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards., • Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement., • Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements., • Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability., • Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans., • Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations., • Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA)., • Track and monitor CAPA effectiveness to ensure issues are resolved and prevented., • Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee., • Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues., • Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy., • Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively., • Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity., • Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction., • Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards., • Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes., • Provide mentorship and guidance to new Engineers/Interns within the organization. Minimum Requirements • Bachelor's degree in engineering, Science, or other related field is required. ASQ, CQE, Six Sigma Green Belt or other applicable certifications are a plus., • A minimum of 7 years' experience in Quality or Engineering., • Experience in a medical device or pharmaceutical industry., • Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred., • Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred. Required Knowledge, Skills, and Abilities • Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans., • Project management and leadership experience is desirable., • Strong analytical and problem-solving skills., • Excellent communication and interpersonal skills., • Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R)., • Ability to work effectively in a cross-functional team environment., • Ability to review and understand technical standards and their requirements for products., • Proficiency in Microsoft Office Products such as Word, Excel, or equivalent software applications. Salary range: $115k - $120k plus 10% annual bonus #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Staff Human Factors Engineer is a key technical contributor responsible for leading usability engineering across the product lifecycle for cardiovascular surgical devices and systems. This role spans front-end innovation (ethnographic research, workflow analysis, opportunity framing, concept ideation, prototyping, and formative evaluation) and back-end validation (use-related risk analysis, labeling/UI development, clinical simulation, and summative/validation studies) to ensure products are safe, effective, and intuitive in complex clinical environments (OR/cath lab/ICU). The position partners closely with Systems Engineering, Design, Clinical, Marketing, Regulatory, Quality, and Software/Hardware teams to embed human factors and usability engineering into Design Controls and to meet FDA and global regulatory requirements (e.g., IEC 62366-1, ISO 14971). The Staff HFE will serve as a subject-matter resource for cardiovascular use environments, mentoring junior engineers and shaping the usability strategy across programs. Job Responsibilities and Essential Duties Front-End Innovation & Formative Research (35%) • Lead contextual inquiry, ethnography, and workflow mapping in cardiovascular surgery and interventional settings (OR, hybrid OR, cath lab)., • Translate insights into user needs, intended use, and use specifications; define user personas and critical tasks., • Drive concept ideation with cross-functional teams; create wireframes, storyboards, and low- to high-fidelity prototypes (software/hardware)., • Plan and execute formative evaluations (simulated-use, heuristic reviews, cognitive walkthroughs), synthesize findings, and iterate designs., • Lead use-related risk analysis (U-FMEA, task analysis, link to ISO 14971 hazard analysis); define critical user tasks and mitigations across labeling, UI, hardware controls, training, and software safeguards., • Ensure HF work products align with Design Controls (21 CFR 820.30) and maintain traceability from user needs risks design inputs verification/validation residual risk., • Plan and execute human factors validation (summative) studies per IEC 62366-1 and FDA HF guidance-including sample rationale, representative users, training decay, test protocols, and data analysis., • Develop labeling and IFU content; ensure clarity of critical information (warnings, precautions, steps, visuals)., • Author HF deliverables for regulatory submissions (e.g., HFE/UE Report, Use Specification, URRA, Critical Tasks, Protocols, Validation Results) supporting 510(k)/PMA/Technical File submissions., • Partner with Clinical, Marketing, and Design to prioritize unmet needs, value propositions, and KOL/stakeholder feedback., • Establish and continuously improve HFE methods, templates, and SOP/WI alignment with AAMI HE75, AAMI TIR50/51, IEC 60601-1-6, IEC 62366-2 guidance, and ISO 9241 best practices., • Mentor junior HF engineers; champion usability and patient/clinician safety while balancing business and technical constraints. Minimum Requirements • Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Cognitive/Experimental Psychology, HCI/UX, Industrial Engineering, or related field required., • Master's degree preferred., • 8 years of experience in Human Factors/Usability Engineering for complex systems, preferably Class II/III medical devices., • Demonstrated experience with OR or interventional workflows strongly preferred (cardiovascular surgery, structural heart, electrophysiology, perfusion, imaging, pumps/dispensers, or energy devices)., • Track record delivering both formative and summative studies and authoring HFE documentation for regulatory submissions., • Deep knowledge of IEC 62366-1 (usability engineering for medical devices), FDA HF Guidance (2016, updates as applicable), AAMI HE75, AAMI TIR50/51, IEC 60601-1-6, ISO 14971, ISO 13485, and 21 CFR 820.30., • Proficiency in use-related risk analysis, task analysis, critical task identification, and linkage to risk controls across UI, labeling, training, and design features., • Expertise conducting formative and summative usability testing-protocols, IRB coordination (as needed), recruitment, moderation, data capture, and analysis., • Strong capability in UI/UX prototyping and design collaboration; familiarity with design tokens and component libraries a plus., • Comfortable working with requirements tools ; experience maintaining traceability to design inputs and risks., • Experience with clinical simulation environments (wet lab, benchtop, high-fidelity simulators) and human performance data capture., • Statistical literacy for HF studies (confidence intervals, error analysis, root cause analysis); proficiency with JMP, Minitab, or equivalent is a plus., • Excellent communication-clear documentation, visual storytelling, and the ability to influence decisions in a matrixed organization. #LI-YA2 #LI-Hybrid About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Job DescriptionQuality Control Microbiology Engineer(s) I, II, III Quality Control Microbiology Engineer I The “Quality Control (QC) Microbiology Engineer I” will support two local sites serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of QC Microbiology, responsibilities of the QC Microbiology Engineer I will include but are not limited to: Microbiological Testing: • Growth Promotion, • Microbial Identification, • Sterility Testing, • Gram Stain, • EndotoxinEquipment Monitoring:, • Ensure equipment is in proper working conditions, • Ensure all equipment is properly maintained/calibrated, • Shipping of test samples and equipment to contract laboratories for testing, • Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).REQUIREMENTS, • Associates degree in a science or relevant field required, • Training in GxP/ GDP, Safety, • Minimum 0-2 years of experience or equivalent experience., • Microbiology testing or within the biopharmaceutical industry experience preferred., • Proficient with computer software; Microsoft Office, • Strong written and oral communication skills, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels, • Must be able to work during the weekend, holidays and as required by the company, • Duties, responsibilities, and activities may change at any time with or without notice.QC Microbiology Engineer II The Quality Control Microbiology Engineer II will support two local sites serving as a support role to clinical and commercial production. The QC Microbiology Engineer II will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer II will include but are not limited to: Microbiological Testing:, • Growth Promotion, • Microbial Identification, • Sterility Testing, • Gram Stain, • EndotoxinEquipment Monitoring:, • Ensure equipment is in proper working conditions, • Ensure all equipment is properly maintained/calibrated, • Shipping of test samples and equipment to contract laboratories for testing, • Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Writing/conducting investigations pertaining to microbiological testing, • Develop and train QC Microbiology Engineer I personnel on relevant business processesREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 2-4 years of experience with microbiological testing or within the biopharmaceutical industry., • Training in GxP/GDP, Safety, • Proficient with computer software such as; Microsoft Office, • MODA/LIMS, • Familiarity with ISO and EU standards, • Strong written and oral communication skills, • Technical writing skills, • Technical training ability, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Supervisory Responsibility, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels., • Employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator., • Duties, responsibilities, and activities may change at any time with or without notice.QC Microbiology Engineer III The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer III will include but are not limited to:, • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experience, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Supervisory Responsibility; Direct reports, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels., • Must have the ability to work in a team-oriented environment and with clients., • Must be able to work during the weekend, holidays and as required by the company

Job Description The Dedicated Support Engineer is responsible for administering preventative maintenance (PM) and troubleshooting, calibrating, and performing electrical safety tests (EST) on automated equipment located in dedicated customer location. The ideal candidate is involved in all areas of the equipment technology, including monitoring work order requests, completing repairs, new equipment inspections and installations, PM’s, EST, inventory management, and documenting all service activities. The Dayshift Field Service Engineer will carry the following Key Accountabilites: • Perform tasks associated with the installation, maintenance, repair, troubleshooting, and assembly of automated microbiology equipment involving basic knowledge and abilities associated with the electronics, robotics, and mechanical processes., • Achieves performance measures associated with the maintenance of equipment, productivity, customer satisfaction, and other performance standards., • Complete all necessary documentation of activities involving the servicing of equipment in accordance with the manufacturer's requirements., • Serves as a resource for the proper operation and maintenance of equipment., • Instructs instrument operators in proper equipment use., • Adheres to the highest level of customer service while managing customer requests with diplomacy., • Provides technical support to customers by telephone as required., • Connects with customers through remote software to troubleshoot and resolve various technical issues. KEY COMPETENCIES: • Must reside in or around dedicated customers., • Must be reliable and able to work independently with limited supervision., • Excellent customer service expertise with outstanding communication skills., • Comfortable working in clinical environments with infectious agents and bio-hazards., • Computer literacy and the ability to read instrument schematics required., • Associate degree in Biomedical Equipment Technology, Industrial, Electrical, or Mechanical Engineering or minimum 2-3 years equivalent formal related training required., • Must be able to have manual dexterity to operate equipment and tools required on the job., • Must occasionally lift and/or move up to 50 lbs., • Must be able to occasionally crouch, kneel, and/or duck into tight spaces of the equipment., • Travel required (Approx. 10% or less) Company DescriptionBe a part of a dynamic and rapidly growing company. With a reputation for innovation, COPAN is the leading manufacturer of collection and transport systems in the world. COPAN’s collaborative approach to innovation in pre-analytics has resulted in the original FLOQSwabs, ESwab, FecalSwab, and UTM, as well as Full Laboratory Automation. COPAN’s collection and systems have been proven to advance the quality of traditional and contemporary microbiology assays. COPAN's automation includes specimen processing, smart incubation, digital imaging, and strong algorithms for the automatic segregation of bacterial cultures, followed by automated colony picking.Be a part of a dynamic and rapidly growing company. With a reputation for innovation, COPAN is the leading manufacturer of collection and transport systems in the world. COPAN’s collaborative approach to innovation in pre-analytics has resulted in the original FLOQSwabs, ESwab, FecalSwab, and UTM, as well as Full Laboratory Automation. COPAN’s collection and systems have been proven to advance the quality of traditional and contemporary microbiology assays. COPAN's automation includes specimen processing, smart incubation, digital imaging, and strong algorithms for the automatic segregation of bacterial cultures, followed by automated colony picking.

Job DescriptionJob Title: Medical Equipment Engineer IIIPosition Summary The Medical Equipment Engineer III serves as a senior technical expert responsible for providing advanced-level installation, troubleshooting, maintenance, and repair of medical and dental equipment both remotely and on-site. This role requires expert technical knowledge, exceptional customer service skills, and the ability to lead and mentor junior engineering staff. The Engineer III acts as a technical escalation point, ensures service excellence, and supervises Medical Equipment Engineer I and II team members while contributing to continuous improvement initiatives and internal training. Key Responsibilities • Provide expert-level technical support for complex dental equipment issues, both remotely and on-site, • Serve as the primary escalation point for unresolved or advanced technical cases from Engineer I and II staff, • Install, configure, inspect, test, and validate advanced dental equipment at customer sites, • Diagnose complex system failures and recommend corrective actions and long-term solutions, • Lead on-site service activities for critical installations, upgrades, retrofits, and major repairs, • Supervise, mentor, and provide technical guidance to Medical Equipment Engineer I & II team members, • Support onboarding and training of new engineers, including field shadowing and skills development, • Review service documentation for accuracy, completeness, and compliance with company standards, • Communicate clearly and professionally with customers, vendors, and internal stakeholders to resolve issues and manage expectations, • Monitor and analyze service metrics such as resolution time, repeat service calls, and customer satisfaction, • Collaborate with engineering, quality, and product teams to provide feedback on equipment performance and design improvements, • Support internal process improvement initiatives and contribute to best-practice development, • Travel regularly to client sites (average 2–7 days per assignment) and provide leadership during multi-day or complex service engagements, • Ensure safe handling, transport, setup, and operation of equipment (up to 50 lbs), • Perform other duties as assigned by managementSupervisory Responsibilities, • Directly supervises Medical Equipment Engineer I and II positions, • Provides performance feedback, coaching, and technical development support, • Assists management with workload planning, scheduling, and skills assessmentsRequired Qualifications, • Associate degree required; Bachelor’s degree in Biomedical Engineering, Electronics, or a related technical field preferred, • 5+ years of hands-on experience servicing medical or dental equipment, with demonstrated advanced troubleshooting expertise, • Prior experience mentoring, leading, or supervising technical staff, • Strong mechanical, electrical, and diagnostic skills across a broad range of clinical equipment, • Proven ability to communicate complex technical information clearly to customers and internal teams, • Excellent customer service, interpersonal, and conflict-resolution skills, • Proficiency in Microsoft Office (Word, Excel, Outlook) and service documentation systems, • Valid driver’s license and ability to travel regularly, • Ability to work independently, prioritize tasks, and manage multiple complex service cases, • Must be able to kneel, bend, stand for extended periods, work in tight spaces, and lift up to 50 pounds

Job DescriptionAssociate Director, Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet customer demand. This role will be responsible for maintaining and overseeing the site Operations scheduling and training capacities for a time period looking ahead to the next 3-6 months. The Associate Director, Manufacturing Operations will understand upcoming needs and constraints and help drive strategy accordingly. This includes the management of all Operations scheduling, training and compliance resources. The Associate Director, Manufacturing Operations is also responsible for assessing the needs of the company to contribute to the big picture by ensuring daily operations run smoothly and as efficiently as possible. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meeting client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contracts, • Looking out 3-6 months to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for processing needs, • Manages all training and compliance activities in the Operations organization, • Responsible for creating, enforcing and measuring Operator training schedules in order to ensure that all production schedules can be carried out, • Creates and maintains a process to ensure that personnel schedules are being accurately and fairly assigned to all Associates, • Supporting and driving special long-term projects and identified and assigned by the PPU Head, • Responsible for creating maintaining and communicating all Operations based KPI’s, • Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices, • Approving job specific curriculum for the training and professional development of department staff, • Responsible for streamlining the batch record review process, • Responsible to understand the profit and loss for the PPU’s as well as all related documentation, and how these items impact Operations, • Driving continuous improvement, • Liaison with support groups for short- and medium-term needs – Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others, • Set team expectations and goals and assists in delivering the business direction for the PPU, • Aligning departmental goals, processes and resource allocation with the organizational strategy, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Direct reports: Associate Manager Training, Associate Manager, Compliance, Scheduling Associate, Quality Engineer Associates. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. REQUIREMENTS, • Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-10 years of cGMP environment, aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation or similar experience., • 5-10 years of leadership experience or equivalent combination of experience., • Deep Understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (able to work with Microsoft Office and corporate scheduling system), • Competencies/Candidate Profile, • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Flexible and able to adapt to company growth and evolving responsibilities, • Accountability, integrity, and strong dedication to regulatory compliance, • Strong business and personnel management acumen, • Strong emotional intelligence, • Ability to think strategically and tactically (detail-oriented), • Strong analytical and problem-solving skills, • Strong written and verbal communication skills, • Drive to create and maintain order in a fluid, technically complex environment, • Continuous improvement mindset, • Ability to multi-task is essential, • Must have the ability to work in a team-oriented environment and with clients, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.Duties, responsibilities, and activities may change at any time with or without notice

Job Description The Graveyard Dedicated Support Engineer is responsible for administering preventative maintenance (PM) and troubleshooting, calibrating, and performing electrical safety tests (EST) on automated equipment located in dedicated customer location. The ideal candidate is involved in all areas of the equipment technology, including monitoring work order requests, completing repairs, new equipment inspections and installations, PM’s, EST, inventory management, and documenting all service activities. The Dedidcated Field Service Engineer will be required of the follwoign KEY ACCOUNTABILITES: • Perform tasks associated with the installation, maintenance, repair, troubleshooting, and assembly of automated microbiology equipment involving basic knowledge and abilities associated with the electronics, robotics, and mechanical processes., • Achieves performance measures associated with the maintenance of equipment, productivity, customer satisfaction, and other performance standards., • Complete all necessary documentation of activities involving the servicing of equipment in accordance with the manufacturer's requirements., • Serves as a resource for the proper operation and maintenance of equipment., • Instructs instrument operators in proper equipment use., • Adheres to the highest level of customer service while managing customer requests with diplomacy., • Provides technical support to customers by telephone as required., • The desire to work in a nightshift setting ., • Must reside in or around dedicated customers., • Must be reliable and able to work independently with limited supervision., • Excellent customer service expertise with outstanding communication skills., • Comfortable working in clinical environments with infectious agents and bio-hazards., • Computer literacy and the ability to read instrument schematics required., • Associate degree in Biomedical Equipment Technology, Industrial, Electrical, or Mechanical Engineering or minimum 2-3 years equivalent formal related training required., • Must be able to have manual dexterity to operate equipment and tools required on the job., • Must occasionally lift and/or move up to 50 lbs., • Must be able to occasionally crouch, kneel, and/or duck into tight spaces of the equipment., • Travel required (Approx. 10% or less).Company DescriptionBe a part of a dynamic and rapidly growing company. With a reputation for innovation, COPAN is the leading manufacturer of collection and transport systems in the world. COPAN’s collaborative approach to innovation in pre-analytics has resulted in the original FLOQSwabs, ESwab, FecalSwab, and UTM, as well as Full Laboratory Automation. COPAN’s collection and systems have been proven to advance the quality of traditional and contemporary microbiology assays. COPAN's automation includes specimen processing, smart incubation, digital imaging, and strong algorithms for the automatic segregation of bacterial cultures, followed by automated colony picking.Be a part of a dynamic and rapidly growing company. With a reputation for innovation, COPAN is the leading manufacturer of collection and transport systems in the world. COPAN’s collaborative approach to innovation in pre-analytics has resulted in the original FLOQSwabs, ESwab, FecalSwab, and UTM, as well as Full Laboratory Automation. COPAN’s collection and systems have been proven to advance the quality of traditional and contemporary microbiology assays. COPAN's automation includes specimen processing, smart incubation, digital imaging, and strong algorithms for the automatic segregation of bacterial cultures, followed by automated colony picking.

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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