Senior Design Assurance Engineer: Medical Device Risk

Job description

Hologic, Inc. seeks an experienced professional to tackle complex problems, applying judgment to methods while ensuring quality and safety across the product lifecycle. The role emphasizes regulatory compliance, risk management, and design controls within a highly regulated medical device environment.

The candidate should have extensive knowledge of FDA QSR 820, ISO 13485, ISO 14971, and EU MDR requirements, with strong leadership and communication skills to guide cross-functional teams.

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Who can apply

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