Senior Design Quality Engineer

Skills Alliance; Marlton (NJ); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Full family medical cover

Leadership pathway

Job summary

Skills Alliance is seeking a Senior Design Quality Engineer to be the quality voice in product development as the company scales its implantable therapy platform. You will own design controls, DHF, and risk management to ensure compliance with ISO 14971 and MDR across projects.

You will lead cross-functional teams, manage CAPAs and post-market data, and mentor colleagues on quality processes while growing into leadership responsibilities.

Qualifications

• 4–7 years in Quality Engineering or Product Development within medical devices.
• Hands-on experience with design controls, DHF and ISO 14971 risk management.
• Strong knowledge of ISO 13485, 21 CFR 820, MDR and MDSAP.
• Active implantable or Class III device experience preferred.

Responsibilities

• Lead design controls across development projects and own the electronic Design History File.
• Author and maintain risk management documentation to ISO 14971 and facilitate cross-functional risk assessments.
• Review and approve internal and contract manufacturer change orders, assessing risk impact.
• Own non-conformances, CAPAs and complaint investigations from root cause through to closure.
• Manage post-market trending and link complaint data back into the risk management system.
• Train and support teams on quality processes with a clear path into leadership.

Skills

Design controls

DHF ownership

Risk management

Cross-functional leadership

Education

BS in Engineering or Life Science

Job description

A fast-growing, commercial-stage medical device company has developed a first-of-its-kind implantable therapy for heart failure patients who have run out of options on medication alone. Their FDA Breakthrough designated device is minimally invasive and already changing lives. They are now looking for a Senior Design Quality Engineer to be the quality voice in product development as they scale.

What you'll do:

• Lead design controls across development projects and own the electronic Design History File
• Author and maintain all risk management documentation to ISO 14971, and facilitate cross-functional risk assessments
• Review and approve internal and contract manufacturer change orders, assessing risk impact
• Own non-conformances, CAPAs and complaint investigations from root cause through to closure
• Manage post-market trending and link complaint data back into the risk management system
• Train and support teams across the business on quality processes, with a clear path into leadership

What you'll bring:

• BS in Engineering or a Life Science field
• 4 to 7 years in Quality Engineering or Product Development within medical devices
• Hands-on experience with design controls, DHF and ISO 14971 risk management
• Solid knowledge of ISO 13485, 21 CFR 820, MDR and MDSAP
• Active implantable or Class III device experience (preferred)
• The confidence to work independently and lead cross-functional teams

This is a chance to join a mission-led company at a pivotal growth stage. You would take real ownership of design quality on a therapy that gives hope back to heart failure patients, with full family medical cover and a genuine route into people leadership.