Senior Design Assurance Engineer

What you'll do

• Lead Design Verification strategy and execution to ensure products meet user requirements and regulatory standards.
• Perform reliability analyses using tools like FTA, failure trending, and forecasting to assess product robustness.
• Manage risk management activities to ensure compliance with FDA, ISO 14971, and ISO 13485 requirements.
• Execute complex test method validation for system and capital equipment including study design and data analysis.
• Identify and resolve reliability and technical risks early to facilitate informed decision-making.
• Drive continuous improvement in Design Assurance processes to increase efficiency and compliance.
• Maintain expert knowledge of regulatory compliance for medical device design, development, and commercialization.
• Coordinate with test labs and external partners to ensure timely completion of design verification activities.

What we're looking for

• Candidates must have a Baccalaureate degree with 4 years of experience, a Master's degree with 2 years of experience, or a PhD.
• Must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
• Perform reliability analyses using tools such as FTA, failure trending, and reliability forecasting.
• Lead risk management activities to ensure compliance with FDA, ISO 14971:2019, and ISO 13485:2016 requirements.
• Complete complex test method validation activities including statistical data analysis like ANOVA and Gage R&R.
• Project management experience (preferred).
• Medical Device Industry experience (preferred).
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and ISO 14971:2019 (preferred).