Senior Design QA Engineer, Medical Devices

Teleflex; Mansfield (MA); On-site; USD 87,000 - 110,000; Full time

Benefits offered by this job

Medical, prescription drug, dental and

Vision insurance

401(k) with employer matching

Paid time off and disability leave

Job summary

Ingenyx, formed after the Teleflex divestiture, seeks an experienced Design Quality Assurance Engineer II to oversee design controls and regulatory compliance. You'll partner with R&D, Manufacturing, Regulatory Affairs and Program Management to ensure robust DHFs, risk management, and successful product development from concept to commercialization.

The role requires a mechanical/ biomedical/ electrical engineering background with 2–5 years in medical device quality or design assurance and

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 2–5 years of experience in medical device quality or design assurance.
• Knowledge of ISO 13485, FDA 21 CFR Part 820 (QSR), EU MDR, MDSAP, ISO 14971.

Responsibilities

• Ensure Design Controls and ISO 13485 design and development compliance.
• Provide quality oversight for design and development activities across product lifecycle.
• Participate in design reviews and approve deliverables meeting standards.
• Ensure DHF completeness and regulatory alignment.
• Lead design control deliverables: plans, inputs/outputs, DV&V, transfer.
• Maintain traceability matrices linking user needs to validation.
• Lead risk management per ISO 14971 and conduct risk assessments.
• Review and approve verification/validation protocols and reports.
• Ensure scientifically sound test methods meeting regulatory expectations.
• Evaluate sample sizes and acceptance criteria; align validation with use.
• Coordinate design change control and re-verification as needed.
• Assess regulatory impact of design changes on submissions.
• Support smooth design transfer to manufacturing with proper docs.
• Review Device Master Record elements for accuracy.
• Collaborate on IQ/OQ/PQ strategies with manufacturing.
• Support FDA inspections, Notified Body audits, and MDSAP.
• Act as SME for design quality systems during inspections.
• Analyze design-related quality metrics and CAPA investigations.

Skills

Analytical thinking

Critical thinking

Documentation skills

Communication skills

Cross-functional influence

Project management

Attention to detail

Regulatory awareness

Education

Bachelor’s degree in Engineering or related field

Job description

Ingenyx, formed after the Teleflex divestiture, seeks an experienced Design Quality Assurance Engineer II to oversee design controls and regulatory compliance. You'll partner with R&D, Manufacturing, Regulatory Affairs and Program Management to ensure robust DHFs, risk management, and successful product development from concept to commercialization.

The role requires a mechanical/ biomedical/ electrical engineering background with 2–5 years in medical device quality or design assurance and