Senior Design Assurance Engineer

Staff Engineer

Work Flexibility: Hybrid

What you will do-

• Lead Design Assurance activities across multiple NPD programs and drive risk management (ISO 14971), usability engineering, and design controls
• Provide guidance on complex technical and quality decisions and mentor junior engineers and influence cross-functional teams
• Act as DAE Functional Lead (FL) for key programs
• Ensure timely completion of Design reviews (DRs);  Risk management deliverables (RMP, DFMEA, RT, etc.) and Verification & validation strategy
• Proactively identify and mitigate program risks and partner with PD, Clinical, Regulatory, Quality, and Operations
• Influence decisions without authority and drive alignment on design inputs, outputs, and usability strategy
• Lead or contribute to Process improvement initiatives; improve DAE processes, templates, and ways of working and support audits and regulatory inspections
• Drive usability strategy across programs and Ensure integration of user needs into product design
• Lead/guide formative and summative evaluations

What you will need-

 

Required-

• Bachelor’s/Master’s in Engineering (Mechanical preferred); relevant experience in medical device / regulated industry
• Experience- 7 years - 10 years
• Strong knowledge of Design Controls (21 CFR 820 / ISO 13485); Risk Management (ISO 14971) and Usability (IEC 62366)

Preferred-

• Good communication and interpersonal skills.
• Exposure to Engineering Drawing, GD&T, Manufacturing process of metals and plastics.

Travel Percentage: 10%

Experience Level

Senior Level