Hybrid Quality Design Assurance Engineer

We are seeking a Quality Design Assurance Engineer with previous Medical Device experience to work for our client a leader in Medical Device Technology. This is a contract to hire positions and is hybrid.

This role will work within high-performance, cross-functional teams to ensure safety, quality, and compliance of commercialized products while continuously improving their value through end-of-life.

Design Assurance drives the ISO 14971 risk management process and the Verification & Validation (V&V) process.

This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports.

This role will be responsible for ensuring quality and compliance through product development and commercialization for medical electrical equipment/systems

Bachelors degree in biomedical, Mechanical, or Electrical Engineering, or related field of study

• Plus 2+ years of experience in design assurance, new product development, or related experience in a highly regulated industry

• Demonstrated use of Quality tools/methodologies

• Strong verbal and written communication skills • Self-motivated with a passion for solving problems and a bias for action

• Effectively work and collaborate in a hybrid (onsite plus remote) environment Preferred qualifications:

• Prior medical device industry experience, particularly with medical electrical equipment • Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations

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