Stryker Group
Associate Engineering Manager, Product Safety
Stryker Group, Portage, Michigan, United States, 49002
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.
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.
Qualifications Minimum Qualifications:
Bachelor’s degree in Engineering or a related technical field.
6+ years experience
Preferred Qualifications:
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.
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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.
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.
Qualifications Minimum Qualifications:
Bachelor’s degree in Engineering or a related technical field.
6+ years experience
Preferred Qualifications:
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.
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