Medical device quality engineer jobs in Paterson, New JerseyCreate job alerts

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.

Job Description Our client in Fairfield, NJ is looking for a Validation Engineer for a Full time position. Pay is $80k-$95k annually DOE • Requires a 4-yr engineering degree or substitute experience; a graduate degree in engineering, technical, or management discipline is preferred., • Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables., • Experience in the medical device/ (GxP) industry is required., • Validation (IQ, OQ, PQ) or PPAP (Production Part Approval Process) required, • Must have knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance Benefits: The company offers a competitive benefits package that includes medical, dental, vision, 401k, pet insurance, etc... Company DescriptionPrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.PrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.

Job Description R&D Senior Engineer – Specimen Management / Medical Devices Location: Franklin Lakes, NJ Rate: $55–$60/hr on W-2 (No C2C) ⏱ Duration: Long-term contract Position Overview We are seeking an experienced R&D Senior Engineer to serve as a key contributor within a Research & Development team supporting a Specimen Management / Specimen Acquisition Platform. This role requires advanced engineering expertise, strong technical judgment, and the ability to independently solve complex product development challenges in a regulated medical device environment. The ideal candidate works under general direction, determines technical approaches independently, contributes to projects of significant impact, and may lead smaller-scope initiatives. This position plays a critical role in design, testing, verification, validation, and risk-based product development. Key Responsibilities Product Development & Technical Leadership • Contribute to R&D projects of considerable scope or lead smaller engineering initiatives., • Independently determine and develop technical approaches to solve complex engineering problems., • Apply sound engineering principles to deliver imaginative, practical, and data-driven solutions., • Design and develop in vivo and in vitro models to evaluate product features and improvements., • Plan, execute, and analyze Design of Experiments (DOE)., • Develop robust test methods, design test fixtures, and perform Measurement System Analysis (MSA)., • Execute and document bench studies, tolerance stack-up analyses, design verification, and validation activities., • Perform statistical analysis, regression analysis, and develop transfer functions., • Collect, record, interpret, and analyze experimental data., • Prepare technical reports and present findings to peers and business leadership., • Ensure compliance with quality system requirements, policies, and procedures., • Apply risk-based development approaches aligned with medical device regulations., • Participate in and lead technical, DFSS, design, and cross-functional reviews., • Direct associates and lead small cross-functional groups when required. Engineering & Technical Expertise • Strong knowledge of engineering first principles., • Proven technical judgment and problem-solving abilities., • Experience with R&D functional planning, requirement generation, and technical reviews across all product development phases., • Proficiency with solid modeling tools such as Pro/ENGINEER (Creo), SolidWorks, or equivalent., • Proficiency in fixture design, basic machining considerations, and test method development., • Strong understanding of Six Sigma (DMAIC) and Design for Six Sigma (DFSS) methodologies., • Knowledge of Measurement Systems Analysis (MSA)., • Strong project management, prioritization, and multitasking skills., • Ability to work independently with minimal direction., • Experience leading small cross-functional teams or directing associates., • Excellent written and verbal communication skills., • Experience in the medical device or life sciences industry., • Hands-on experience with statistical tools and experimental analysis software., • Experience supporting supplier development and component qualification., • Industry, • Medical Equipment Manufacturing, • Job Functions, • Engineering, • Skills, • Medical Device Product Dev

Job Description Our client in Fairfield, NJ is looking for an onsite, direct hire Manufacturing Industrial Engineer. Pay: $120k-$130k The ideal candidate will have an engineering background in mechanical engineering, industrial engineering, systems engineering, value engineering, or related engineering field with concentrated technical knowledge and previous experience in precision metals and plastics manufacturing and/or complex finished device assemblies. Responsibilities: • This role is fundamentally based on long-standing best practices in industrial engineering principles: identifying waste, defining value streams, productivity optimization, kanban setups, takt time studies, labor tracking, ergonomics, material flow, pFMEA, and similar Lean Six Sigma tools., • Support new business development with the purpose of generating accurate and detailed costing proposals that exceed customer expectations for quality, price, and delivery., • Bachelor's degree in Engineering (Mechanical, Industrial engineering, Systems engineering, Value engineering), • Minimum of 5 years of experience in value engineering, industrial engineering, manufacturing costing, or related role in the manufacturing industry, with specific experience utilizing industry 4.0 best practices and/or Lean, • Experience working for a Contract Manufacturer or OEM, • Strong engineering background with a solid understanding of manufacturing processes, materials, and equipment, • Ability to identify the best possible manufacturing processes, • Proficiency in using SolidWorks or equipment CAD/CAM software packages for estimating and DFM purposes, • Experience in product level design for manufacture (DFM), • Ability to collaborate across engineering Centers of Excellence for multi-plant vertically integrated proposals, • Excellent analytical and problem-solving skills, • Strong attention to detail and accuracy, • Effective communication and interpersonal skills, • Ability to work independently and as part of a cross-functional team, • Knowledge of industry standards and best practices in cost estimation

Job Description Our client in Fairfield, NJ is looking for a Senior Product Release Engineer for a Full time position. Pay is $110-125k annually DOE Responsibilities: • Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements., • Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs., • Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes., • Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities., • Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities., • Understand and meet Regulatory (FDA) requirements and processes for development., • Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s., • Bachelor’s degree in mechanical engineering or biomedical engineering., • Minimum of 10 years of medical device experience., • Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products., • Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact on company objectives.

Job Description Job Details: - Job: Staff Engr, Product Development Location: Franklin Lakes, NJ (07417) Type: Hybrid (4 days a week in Onsite) Job Description: The engineer in this role will be a key contributor on the R&D Team, specifically supporting the Specimen Acquisition Platform under the Enterprise Cost-To-Win (eCTW) program. The individual in this position will have a complete understanding of a wide application of engineering principles, theories, concepts, and has a full knowledge and/or expertise of other related disciplines. He/She will provide solutions that are imaginative, thorough, and practical to a wide range of complete problems. He/she will be responsible for providing product development and engineering support by playing critical role in developing / integrating / analyzing / testing / and troubleshooting medical device/IVD components and systems relating to collection, preservation, manipulation and analysis of biological samples including human blood samples. Key Responsibilities: · Works under general direction to guide design and development of advanced biomedical solutions that are needed to meet key business objectives relating to the existing and new medical device products. · Guides the successful completion of major programs and at times will function in a project leadership role. · Represents the organization as the prime technical contact on contracts and projects. · Interacts with senior external personnel on technical matters often requiring coordination between organizations. · Independently determines and develops approach to solutions. · Designs and develops in vivo and invitro models to evaluate product features and improvements. · Drives creative, logic and risk-based approaches to resolve technical challenges and tradeoffs under business constrains including strong capacity for critical thinking and analysis. · Independently determines and develops technical solutions to complex problems using sound engineering principles and design of experiments (DOE) while utilizing experimental, computational and/or analytical methods. · Develops robust test methods, design test fixtures and executes measurement system analysis. · Writes, implements, and leads hands-on benchtop studies, tolerance stack up analysis, design verification, validation, vendor interactions, material specifications, component specifications, troubleshooting and/or root-cause analysis in order to evaluate product performance & improvements. · Performs data analysis using statistical tools, generate reports and present recommendations to peers and business leaders. · Supports and at times lead material, design and/or process changes to existing products by following design control process and generating well-documented research and analyses records. · Demonstrate strong drive for results and clear accountability for successful and timely completion of designated tasks and projects. · Contribute to the development of new product development capabilities, methodologies and expertise by staying aware to trends in the computational and visualization technology fields and actively seek training to further improve skills. · Collects, records, reports, interprets, and analyzes data, presents results to peers and business leadership. · Provides advanced engineering skills and product evaluation support to the platform towards building business cases for new opportunities. · Contributes to development and implementation of R&D strategies through evaluation of new business opportunities, technologies, and possible acquisition targets. · Ensures compliance with BD quality policies, procedures, and practices through appropriate communication, training and education of sound quality assurance principles.. Strength in scientific and engineering fundamentals based on first principles understanding including critical thinking and systematic problem-solving skills as well as business acumen and learning agility are essential requirements to be successful in this position. Minimum Requirements: · Strong technical judgement and leadership skills. · Demonstrated capability of leading R&D product development projects. · Experience in guiding team/individuals to develop technical solutions to complex problems. · R&D functional planning, requirement generation and technical (DFSS/Design/Cross functional) reviews for all product development phases. · Proficiency in solid CAD modeling (Creo, SolidWorks or equivalent) and design for manufacturability including injection molded and related systems and assemblies. · Product development considerations for tightly controlled, high-volume manufacturing process. · Disciplined in phase-gate product development and project planning. · Strong project management, prioritizing, and multi-tasking skills to work within tight eadlines. · Experience in directing associates and leading small cross-functional groups is a plus. · Proficiency with statistical methods including DoE and data analysis using software such as Minitab. · Proficiency with fixture design including basic machining considerations and developing test methods (fixture design and hands-on testing). · Understanding of Measurement Systems Analysis (MSA). · Proficiency with any of FEA and/or CFD modeling software is a plus. · Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies. · Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams. · Strong creative, analytical, and problem-solving skills required. · Good written and verbal communication skills.