Staff Engineer, Advanced Operations
Stryker · Mahwah, NJ +2 more
Manufacturing OperationsFull-time$89k–$149kCompany career page
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Role summary
Stryker seeks a Staff Engineer to lead biologics process development and new product introduction, providing technical oversight of manufacturing processes, equipment qualification, and regulatory documentation across internal and supplier operations.
What they're looking for
- Bachelor's degree in Mechanical Engineering or related engineering discipline
- Minimum 7 years of manufacturing or process development engineering experience
- Minimum 7 years of experience in regulated manufacturing environments
- Proficiency in process validation, statistical analysis, and verification/validation methodologies
- Strong understanding of engineering drawings, specifications, and GD&T
- Experience with Design for Manufacturing, process capability studies, and MSA
- Preferred: biologics manufacturing or process development background
What you'll be doing
- Lead development, optimization, and control of upstream and downstream biologics manufacturing processes
- Conduct process characterization, variability, and robustness studies to establish control strategies
- Evaluate, qualify, and support installation of manufacturing equipment and components
- Generate and review technical documentation including PFMEAs, Control Plans, SOPs, and validation protocols
- Mentor engineers and provide technical guidance across product portfolios
Privacy & handoff
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