Senior Design Quality Engineer - Medical Device - Medford, NJ

Senior Design Quality Engineer

My client is driven by a mission rooted in innovation, transparency, and patient benefit, the company emphasizes excellence in design, adherence to global regulatory standards, and the development of a collaborative, talent-focused workplace. With continued investment, substantial venture backing, and ongoing expansion of its technology platform, the organization remains at the forefront of advancing next-generation treatment solutions for chronic heart failure.

The key responsibilities of the Senior Design Quality Engineer are:

• Serve as the Quality representative on cross-functional product development teams.
• Ensure compliance with design control procedures (e.g., FDA 21 CFR Part 820, ISO 13485).
• Review and approve design documentation, including design inputs, outputs, verification, validation, and design transfer activities.
• Support the development and maintenance of Design History Files.
• Lead and support risk management activities in accordance with ISO 13485:2016, 21 CFR Part 820 and MDSAP
• Facilitate risk assessments including FMEA/FMECA, hazard analyses, and risk/benefit evaluations.
• Ensure risk controls are effectively implemented, verified, and documented
• Collaborate with Manufacturing and Operations to ensure smooth design transfer and process readiness.
• Review production specifications, process validations, and inspection criteria.
• Support process validation activities and ensure quality requirements are maintained in production.

The successful Senior Design Quality Engineer will have:

• Bachelor's degree in Engineering, Life Sciences, or a related technical field (Master's preferred).
• 5+ years of experience in Design Quality, Quality Engineering, or related roles within the medical device industry.
• Strong knowledge of design controls and product development processes.
• Deep understanding of ISO 13485 requirements.
• Experience with risk management standards (ISO 14971).
• Familiarity with verification & validation methodologies and statistical analysis tools.
• Experience with CAPA systems, change control, and document management systems.

My client can offer the following:

• Full Coverage Medical Benefits - Employee + family contribution is 100%
• Paid Vacation, floating holidays, and sick time.
• Paid Holidays
• 401k Match (up to 6%)
• Annual bonus eligibility

• Job summary:

  Sector Engineering & Manufacturing Sub Sector Maintenance, Reliability Industry Industrial / Manufacturing Location Moorestown Contract Type Permanent