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

Job Description The Process Engineer I ensures manufacturing processes are efficient, cost-effective, compliant with MICRO’s quality standards, and capable of consistently producing products that meet customer specifications. JOB OUTCOMES The Process Engineer I will: · Contribute to measurable improvements in manufacturing efficiency, product quality, and cost reduction through active participation in engineering projects. · Support the implementation of equipment upgrades, tooling enhancements, and new processes that reduce downtime and improve resource utilization. · Deliver accurate documentation and data analysis that enhance process understanding, enable validation, and ensure manufacturing consistency. · Assist in root cause investigations and corrective actions that lead to sustained improvements in product performance and compliance. ESSENTIAL DUTIES AND RESPONSIBILITIES Process Improvement – 60% • Collaborate as a contributing member of cross-functional project teams focused on process and product improvements., • Recommend and justify changes to equipment, work methods, or processes to enhance efficiency and resource utilization., • Participate in the design, selection, and specification of manufacturing equipment and tools., • Support the installation, maintenance, and upgrade of equipment to ensure smooth integration into production., • Assist in developing and optimizing tooling and manufacturing processes to meet performance and quality targets., • Investigate process issues to identify root causes and partner with Quality Engineers to implement effective corrective actions. Process Analysis & Documentation – 40% • Collect, organize, and analyze production data to identify trends, variances, and improvement opportunities., • Document and diagram manufacturing processes to ensure clarity, consistency, and compliance., • Draft detailed work instructions and standard operating procedures with guidance from senior engineers., • Contribute to the creation of validation documentation for new products, design changes, or process updates., • Assist in the quarantine, documentation, and evaluation of nonconforming products and materials., • Interpret and support the use of Process Flow Diagrams (PFDs), Failure Mode and Effects Analyses (FMEAs), and Process Control Plans (PCPs) to maintain process integrity and quality standards. TALENT MANAGEMENT This position has no talent management responsibilities. QUALIFICATIONS EDUCATION AND EXPERIENCE · Bachelor’s degree in Engineering or a related field is required. · At least 2-4 years of engineering experience is required. LICENSE AND CERTIFICATION · None TECHNICAL SKILLS · Blueprint reading · Geometric Dimensioning and Tolerancing (GD&T) · Statistical Process Control (SPC) · ERP · Minitab Statistical Software · Metal fabrication · Medical device manufacturing · MS Office Suite OTHER SKILLS · Verbal communication · Written communication · Organizational Skills · Problem solving While performing the duties of this Job, the employee is regularly required to sit; and talk and hear. The employee is frequently required to stand; walk; use hands to touch, handle, or feel and reach with hands and arms. The employee must lift, push, pull, carry and/or move up to 10 pounds frequently, and between 10 and 25 pounds occasionally. While performing this Job, the employee is regularly required to demonstrate manual and spatial dexterity sufficient to operate machinery for precision work. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to vibration. The employee is occasionally exposed to wet and/or humid conditions; risk of electrical shock; and odors, dusts, mists, fumes and/or airborne particles. The noise level in the work environment varies from moderate to loud, based on the department/ work area.

Job Description The Process Engineer ensures manufacturing processes are efficient, cost-effective, compliant with MICRO’s quality standards, and capable of consistently producing products that meet customer specifications. JOB OUTCOMES The Process Engineer will: · Lead projects that deliver measurable improvements in process efficiency, product quality, and cost reduction across assigned manufacturing areas. · Act as a Subject Matter Expert (SME) to resolve complex technical challenges, optimize process performance, and support cross-functional teams. · Drive sustainable process improvements through data-driven decision-making, root cause analysis, and the implementation of corrective and preventive actions. · Ensure that manufacturing processes consistently meet internal quality standards and customer specifications while remaining scalable and cost-effective. ESSENTIAL DUTIES AND RESPONSIBILITIES Process Improvement – 60% • Lead or actively contribute to cross-functional project teams focused on improving process efficiency, product quality, and cost performance., • Recommend and implement improvements to equipment, tooling, and work methods to increase throughput and optimize resource utilization., • Collaborate in the design and specification of new equipment and tooling to meet production and quality requirements., • Support the installation, testing, and optimization of new or modified equipment to ensure successful integration into manufacturing operations., • Assist in developing and refining manufacturing processes to improve repeatability, yield, and operational reliability., • Conduct root cause analyses of process issues and partner with Quality Engineers to implement sustainable corrective and preventive actions. Process Analysis & Documentation – 40% • Collect and analyze production and process data to identify trends, deviations, and improvement opportunities., • Create clear, accurate process documentation including diagrams, workflows, and written instructions., • Draft and revise detailed work instructions and standard operating procedures (SOPs) with input from senior engineers., • Contribute to the development of validation documentation for new parts, design changes, and process updates., • Assist in managing nonconforming material by documenting issues, coordinating evaluations, and supporting disposition activities., • Interpret and apply tools such as Process Flow Diagrams (PFDs), Failure Mode and Effects Analyses (FMEAs), and Process Control Plans (PCPs) to ensure process control and risk mitigation. TALENT MANAGEMENT This position has no talent management responsibilities. QUALIFICATIONS EDUCATION AND EXPERIENCE · Bachelor’s degree in Engineering or a related field is required. · At least 4-6 years of engineering experience is required. LICENSE AND CERTIFICATION · None TECHNICAL SKILLS · Blueprint reading · Geometric Dimensioning and Tolerancing (GD&T) · Statistical Process Control (SPC) · Measurement Systems Analysis (MSA, GR&R) · Design of Experiments (DOE) · Statistical software systems · ERP · Minitab Statistical Software · Metal fabrication · Medical device manufacturing · MS Office Suite OTHER SKILLS · Verbal communication · Written communication · Organizational skills · Problem solving While performing the duties of this Job, the employee is regularly required to sit; and talk and hear. The employee is frequently required to stand; walk; use hands to touch, handle, or feel and reach with hands and arms. The employee must lift, push, pull, carry and/or move up to 10 pounds frequently, and between 10 and 25 pounds occasionally. While performing this Job, the employee is regularly required to demonstrate manual and spatial dexterity sufficient to operate machinery for precision work. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to vibration. The employee is occasionally exposed to wet and/or humid conditions; risk of electrical shock; and odors, dusts, mists, fumes and/or airborne particles. The noise level in the work environment varies from moderate to loud, based on the department/ work area.

Job DescriptionAbout Essenlix Corporation: Essenlix Corporation is a fast-growing medical device company focused on developing innovative point-of-care (POC) diagnostic platforms for decentralized clinical testing. Our technologies integrate microfluidics, precision instrumentation, and scalable manufacturing to enable accessible, high-quality diagnostics worldwide. Our overseas manufacturing facility in China is ISO 13485 certified. We are strengthening our U.S.-based development and quality systems while advancing next-generation diagnostic platforms from early-stage feasibility through commercialization. Position Summary: We are seeking an experienced Senior Microfluidic Mechanical Design Engineer to lead microfluidic cartridge development, sample handling system design, and mechanical integration for compact diagnostic instrumentation platforms. This role emphasizes microfluidic system design and sample handling mechanisms, followed by precision mechanical architecture and manufacturability in a regulated medical device environment. Key Responsibilities Microfluidic Cartridge Development: • Design and optimize cartridge-based microfluidic systems., • Develop and refine flow paths, reaction chambers, and optical interface regions., • Address bubble control, sealing integrity, dead volume reduction, and fluid reliability., • Support injection-molded microfluidic component design and tooling., • Implement bonding processes such as ultrasonic welding and thermal sealing. Sample Handling Fluid Management: • Design and optimize sample loading and metering mechanisms., • Develop solutions for capillary flow, mixing, contamination control, and fluid stability., • Validate robustness of sample handling under environmental variation., • Ensure repeatability and manufacturability of sample interface systems. Mechanical System Design: • Lead structural design of compact diagnostic instruments., • Perform tolerance stack-up analysis for precision alignment., • Design mechanical interfaces between disposable cartridge and instrument., • Develop thermal management structures supporting precision temperature control., • Ensure mechanical durability under transport and field use conditions. Manufacturing Compliance Support: • Support design-for-manufacturing (DFM) and production scale-up., • Collaborate with overseas manufacturing teams on design transfer., • Generate mechanical documentation within ISO 13485 design control framework., • Participate in risk analysis and verification activities. Qualifications: Required: • Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field., • 5+ years experience in microfluidic device (Lab on a Disc prfered) or cartridge-based system development., • Experience in sample handling and fluid management system design., • Experience with injection-molded components and tooling., • Strong understanding of sealing, bonding, and fluid path reliability., • Proficiency in CAD (SolidWorks or equivalent)., • Experience in precision mechanical system design. Preferred • Experience in IVD or diagnostic instrumentation., • Experience in centrifuge-based microfluidics (centrifugal microfluidics / (Lab-on-a-Disc)), including sample metering, separation, washing, mixing, and reagent handling on disposable cartridges/discs; ability to translate assay workflows into robust fluidic sequences., • Experience with ultrasonic welding or thermal bonding processes., • Experience transferring products to manufacturing., • Familiarity with ISO 13485 design control requirements., • Experience working with cross-border manufacturing teams. Compensation Benefits: • Competitive salary based on experience., • 401(k) retirement plan., • Health insurance., • Paid time off. How to Apply: Please submit your resume.

Job Description The Quality Systems Manager is responsible for leading the development, implementation, and continuous improvement of the Quality Management System (QMS) of Micro. This role ensures compliance with applicable regulatory requirements, industry standards, customer requirements, and internal policies while driving operational excellence across quality processes. The position partners closely with cross-functional leaders to promote a culture of quality, compliance, and continuous improvement. JOB OUTCOMES The Quality Systems Manager is expected to: · An effective and audit-ready Quality Management System is maintained that consistently supports compliance with customer requirements, regulatory requirements, certification standards, and business objectives. · Customer, regulatory, certification, and third-party audits and inspections are successfully completed with minimal findings, sustained approvals, and continued organizational confidence in the effectiveness of the Quality Management System. · Corrective and preventive actions are implemented, verified for effectiveness, and completed in a manner that eliminates root causes and prevents the recurrence of quality system issues. · Complaints, deviations, nonconformances, and related quality system events are investigated, resolved, and closed within established timeframes while maintaining compliance and minimizing organizational risk. · Quality system improvements strengthen compliance, reduce risk, improve operational effectiveness, and enhance the organization's ability to consistently meet customer and regulatory expectations. ESSENTIAL DUTIES and RESPONSIBILITIES Quality Systems Leadership • Lead and continuously improve the Quality Management System to sustain compliance with applicable regulatory, customer, and business requirements., • Govern quality system processes to keep them effective, sustainable, and aligned with ISO, FDA, GMP, and applicable standards — preventing lapses that jeopardize certifications or approvals., • Serve as the subject-matter expert on quality systems and regulatory compliance, giving leaders and teams trusted guidance that drives confident, compliant decisions., • Facilitate Management Review with meaningful performance data that equips leadership to make informed decisions and prioritize improvements. Compliance & Auditing • Execute an effective internal audit program that surfaces risks early, drives corrective action, and delivers measurable continuous improvement., • Host and manage external audits and regulatory inspections so they run smoothly and sustain the company’s certifications, registrations, and customer approvals., • Drive resolution of audit findings within established timelines and verify their effectiveness, eliminating overdue and recurring issues., • Serve as the primary contact for regulatory bodies and third-party auditors, building transparent and constructive relationships. Complaints, CAPA & Continuous Improvement • Manage complaint handling, investigation, nonconformance, and CAPA processes to consistently meet regulatory and customer requirements., • Drive problems to root cause and implement verified corrective actions so that issues do not recur., • Lead continuous improvement initiatives that measurably reduce quality risk, strengthen compliance, and improve process efficiency., • Analyze quality system data and trends to target and act on systemic improvements after issues occur. Document Control & Training • Maintain document control processes that keep quality system documentation accurate, accessible, revision-controlled, and compliant at all times., • Keep all SOPs, policies, and procedures current and aligned with actual practice, eliminating outdated or uncontrolled documents., • Deliver quality system training programs that build employee competency and meet compliance requirements., • Monitor training completion and effectiveness to keep the organization audit-ready and operationally capable. TALENT MANAGEMENT Directly supervises multiple employees in the Quality department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. • Lead, mentor, and develop quality systems staff, • Drive accountability to deliver on Quality Goals, • Foster a strong quality culture across the organization EDUCATION AND EXPERIENCE · Bachelor’s degree in Engineering, Quality or a related field is required · 8-10 years of quality experience in a manufacturing environment or equivalent combination of education and experience is required · Strong experience managing Quality Management Systems in a regulated industry (e.g., medical device, manufacturing) · Experience in developing one or more Quality Systems (e.g., CAPA, Internal Audit program, Complaints) · Experience leading audits is required · Experience hosting audits is required · Experience with electronic QMS systems preferred LICENSE AND CERTIFICATION Preferred Certifications • ASQ Certified Quality Manager (CQM) / Certified Quality Engineer (CQE), • Lead Auditor certification (ISO standards) · Six Sigma (Green Belt/Black Belt) preferred OTHER SKILLS · Ability to work on multiple projects · Excellent leadership and team management ability · Strong ability to present data/information to various levels of management and at the appropriate level of detail · Strong ability to assess risk/impact so that projects/initiatives can be appropriately prioritized · Must have exceptional organizational skills, ability to meet deadlines, thrive in a fast-paced environment and be able to solve problems effectively · Proficient with MS Office Suite. Advanced skills in Excel for data analysis is preferred

Job Description Job Title: Manufacturing Engineer Job Description This Manufacturing Engineer role focuses on sustaining engineering and supporting the production of complex, high-value semiconductor capital equipment in a low-volume, high-complexity, engineer-to-order environment. You will work hands-on with sophisticated electromechanical systems, serving as the first line of support on the manufacturing floor to troubleshoot mechanical, electrical, and integration challenges during assembly, build, and test. The position offers direct impact on production and product performance, extensive cross-functional collaboration, and exposure to cutting-edge equipment used in AI, semiconductor, and advanced technology applications. Responsibilities • Provide hands-on support during assembly, integration, and final testing of complex semiconductor capital equipment., • Troubleshoot and resolve mechanical and electrical issues, including fit, tolerance, integration, and system-level interactions., • Serve as the first responder for production issues on the manufacturing floor and drive thorough root cause analysis and resolution., • Identify design or process issues and provide clear feedback to engineering teams, including design redlines and improvement recommendations., • Collaborate closely with design engineering, quality, supply chain, and production teams to ensure smooth builds and issue resolution., • Support continuous improvement initiatives to prevent repeat issues and enhance manufacturing processes and product reliability., • Develop, update, and refine work instructions and build documentation to support consistent, high-quality assembly and test processes., • Provide design feedback related to high vacuum systems and other complex subsystems to improve manufacturability and serviceability., • Work in a fast-paced, floor-driven environment, managing multiple issues and priorities while maintaining clear communication with technicians and leadership., • Travel up to approximately 10% domestically and internationally as needed to support builds, troubleshooting, or cross-site collaboration. Essential Skills • Strong mechanical aptitude with practical, hands-on experience in manufacturing and troubleshooting complex equipment., • Working knowledge of electrical systems and the ability to read and interpret electrical schematics., • Experience in manufacturing engineering within semiconductor capital equipment, large medical device, or similarly complex electromechanical systems that include electrical, mechanical, and software components., • Proficiency in troubleshooting mechanical and electrical issues on complex systems, including fit, tolerance, and integration challenges., • Ability to apply GD&T (Geometric Dimensioning and Tolerancing) concepts in a manufacturing and assembly context., • Comfort working in a fast-paced, shop-floor-focused environment with frequent hands-on engagement with equipment and builds., • Execution-focused mindset with a strong emphasis on problem-solving and issue resolution rather than design-only work., • Adaptability to work across multiple issues and shifting priorities in a low-volume, high-complexity, engineer-to-order setting., • Strong communication skills, with the ability to interact effectively with technicians, engineers, and leadership., • Willingness and ability to travel up to approximately 10% domestically and internationally as required., • Willingness to relocate to be fully onsite at the manufacturing facility. Additional Skills & Qualifications • Experience in semiconductor capital equipment or large medical devices that integrate mechanical, electrical, and software components is highly desirable., • Experience working with high vacuum systems and providing design feedback and redlines to improve manufacturability is a strong plus., • Comfort working in environments where each system may be customized, requiring flexibility and strong problem-solving skills., • Interest in working on complex, high-value systems used in AI, semiconductor, and advanced technology applications., • Motivation to have direct impact on production and product performance in a role that is not siloed and offers high visibility., • Desire to work cross-functionally across engineering, manufacturing, and supply chain in support of critical production ramps., • Preference for low-volume, high-complexity manufacturing rather than repetitive, high-volume production work.Job Type & Location This is a Permanent position based out of Somerset, NJ. Pay and Benefits The pay range for this position is $76000.00 - $96500.00/yr. -ask me for benefits information Workplace Type This is a fully onsite position in Somerset,NJ. Application Deadline This position is anticipated to close on Jul 18, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Five or more years of direct experience with engineering related activities in a technical or critical environment (data center, nuclear power, hospital, pharmaceutical, semiconductor, industrial/commercial field engineering). Seven or more years of direct experience with facilities engineering rela

Lead supplier quality projects, component qualification changes, quality agreements, and process/product improvement initiatives using project management, Quality Engineering, and continuous improvement tools. The Staff Source Quality Engineer provides global Source Quality leadership for direct and

Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable regulatory agencies. The Staff Quality Engineer, ECMP Work Stream Leader is a key role within the Enterpris

Supplier Quality/Quality Engineering in medical device and/or pharma. Provide quality engineering support (incoming controls, sampling plans, problem solving 8D/5Why, data analysis) to prevent recurrence of issues. Lead supplier quality activities to ensure externally supplied materials, components,