Principal Design Assurance Lead — Medical Devices

Custom Search Inc.; Minneapolis (MN); On-site; USD 120,000 - 160,000; Full time

Job summary

Custom Search Inc. seeks a Principal Design Assurance Engineer to lead design quality from concept to transfer for a medical device program. You will guide cross-functional teams, drive risk-based decisions, and ensure audit-ready DHF and strong V&V plans.

This role partners with R&D, QA, Ops, and Marketing to meet ISO/FDA expectations while maintaining innovation velocity. The ideal candidate will bring 10+ years in design assurance, proficiency with ISO 14971, design controls, DHF, and a track

Qualifications

• BS in Engineering or equivalent combination of education and experience.
• 10+ years of design assurance/quality engineering in medical devices.
• Strong knowledge of ISO 14971, design controls, DHF and regulatory expectations.
• Experience with complex systems (mechanical/electrical/software).
• ASQ CQE certification is a plus; proficiency in SolidWorks beneficial.

Responsibilities

• Serve as the Quality representative on cross-functional development teams from design through transfer and post-launch improvements.
• Own product safety and quality across design and process development, ensuring alignment with inputs/outputs and regulatory requirements.
• Maintain an audit-ready DHF including structure, deliverables, and procedures.
• Lead risk management activities (plans, analyses, FMEAs, reports) across the lifecycle.
• Drive alignment on risk controls, traceability, and documentation for regulatory reviews.
• Provide QA support across all development phases including design verification/validation and testing.
• Partner with R&D on test plans, data analysis, specs, and acceptance criteria.
• Support CAPA, nonconformances, and supplier qualifications; drive root cause analysis.

Skills

Design Assurance

Risk Management

Verification

DHF

ISO 14971

Education

BS in Engineering

Tools

SolidWorks

Statistical software

Job description

Custom Search Inc. seeks a Principal Design Assurance Engineer to lead design quality from concept to transfer for a medical device program. You will guide cross-functional teams, drive risk-based decisions, and ensure audit-ready DHF and strong V&V plans.

This role partners with R&D, QA, Ops, and Marketing to meet ISO/FDA expectations while maintaining innovation velocity. The ideal candidate will bring 10+ years in design assurance, proficiency with ISO 14971, design controls, DHF, and a track