Principal Product Development Quality Engineer

Senior or Principal Product Development (Design Assurance) Quality Engineer

A long term client company of Agile Search has recently entered into a strategic partnership with a global medtech and is experiencing growth.

This newly created opportunity is On-site and will report to the company's VP of Quality and Regulatory.

This key hire will own the Design Control and design-risk-management processes across the full product lifecycle, concept to launch, for sterile catheter, electromechanical, and software-based medical devices.

This is a hands‑on design‑quality engineering opportunity partnering across R&D, Operations, Regulatory, and Commercial to build quality into products from the start and ensure compliance with FDA QMSR, ISO 14971, and ISO 13485.

• Full-cycle Design Controls: lead the design quality process from concept through launch and design transfer, ensuring projects meet internal procedures and FDA/ISO requirements.
• Design risk management: lead cross‑functional hazard analysis, risk evaluation, and periodic risk‑file review to drive quality by design.
• Design Verification & Validation: develop and maintain V&V methodologies and best practices that protect product quality and launch timelines.
• Design transfer: partner with Operations and Operations Quality to move products cleanly into manufacturing.
• Quality Engineering SME: statistical analysis, failure investigation, hazard/risk analysis, and data trending, including Post‑Market Surveillance support.
• Software and cybersecurity (secondary emphasis): support software design quality and V&V per IEC 62304, and contribute to product cybersecurity activities.

• BS in Mechanical, Electrical, Biomedical, or related engineering.
• 5+ years of full‑cycle design assurance in medical device design and manufacturing, with a proven record of NPI transfers to operations.
• Working knowledge of 21 CFR 820, ISO 14971, ISO 13485, ISO 10993, IEC 60601, and IEC 62304.
• Design V&V and quality tools: FMEA, URRA, SPC, RCA, MSA, Gage R&R; statistical analysis in Minitab; process validation and equipment qualification (IQ/OQ/PQ).
• Experience with regulatory‑submission design documentation and managing third‑party development/test organizations.
• Clear communicator; adaptable, collaborative, and strong critical reasoning.

5-8 years of applicable experience $135-160K (base salary) plus discretionary bonus and benefits

9+ years of applicable experience $160K+ (base salary) plus discretionary bonus and benefits

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