Associate Engineering Manager, Product Safety

StrykerPortage, MI
2dHybrid

About The Position

As a Product Safety Engineering Manager, you lead and develop a team of product safety engineers supporting both new product development and post-market activities. Reporting into senior engineering leadership, you set strategic direction for the product safety function while ensuring regulatory compliance, high-quality execution, and predictable product launches. You partner closely with R&D and Product Engineering teams to embed safety and compliance into design, development, and sustainment activities. This role balances people leadership, cross-functional collaboration, and technical oversight to drive business and compliance outcomes. Check out our Instruments product portfolios: Stryker Neurosurgical Stryker Surgical Technologies Stryker IVS This role is hybrid with 4+ days a week on-site in Portage, MI.

Requirements

  • Bachelor’s degree in Engineering or a related technical field.
  • 6+ years experience

Nice To Haves

  • Demonstrated ability to lead, coach, and develop technical professionals while setting clear performance expectations in direct or indirect leadership positions.
  • Strong knowledge of medical device (or other regulated industries) regulations and standards related to product safety, including FDA and international requirements.

Responsibilities

  • Lead and develop a high-performing team of product safety engineers by setting clear direction, coaching performance, and fostering an engaged, inclusive team culture that delivers consistent, high-quality results.
  • Partner with R&D and Product Engineering leaders on workforce and resource planning to meet current and future business needs.
  • Champion product safety across the product lifecycle, ensuring requirements are understood, integrated, and executed effectively from concept through commercialization and post-market support.
  • Drive accountability for successful product certifications, on-time launches, and adherence to quality and regulatory expectations.
  • Enable clear, proactive communication across teams to identify risks early, resolve issues efficiently, and maintain project momentum.
  • Oversee preparation for and participation in audits, serving as a product safety subject matter expert and primary interface with external certification and regulatory bodies.
  • Guide cross-functional teams on compliance testing, design decisions, and sustainment activities related to product safety.
  • Assess and manage business risk related to product safety, compliance strategy, process improvements, and technology initiatives.
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