Senior Design Quality Engineer

About Our Client

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

Job Description

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.

MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

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.

What's on Offer

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