Senior Compliance Engineer

What you'll do

• Lead compliance engineering and product safety strategy for the Monadnock program and other product development efforts.
• Interpret applicable standards to derive system-specific product safety and compliance requirements for design teams.
• Partner with multi-disciplinary design engineers from requirements development through design review to compliance verification.
• Manage relationships with external verification laboratories and coordinate compliance testing for EMC and electrical safety.
• Author and co-author compliance test plans, protocols, methods, and reports for verification execution.
• Support risk management activities and ensure compliance findings drive appropriate requirements and risk updates.
• Track compliance status across the program and drive timely resolution of all findings.
• Maintain all compliance and product safety documentation within the company quality management system.

What we're looking for

• Minimum of 8 years of medical device compliance and product safety engineering experience required.
• Bachelor’s degree in Electrical, Mechanical, Biomedical, Systems Engineering, or a closely related field required.
• Solid, hands-on experience with medical device compliance testing and engineering required.
• Strong working knowledge of IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485, FDA 21CFR 820, IEC 62304, and ISO 10993 required.
• Demonstrated experience working with external compliance and test laboratories like TÜV required.
• Experience interpreting standards and translating clauses into system-specific design and verification requirements required.
• Experience with design reviews and design control procedures required.
• Export Control: “A successful candidate.