Staff Engineer, Advanced Operations
$89.3k - $148.8kStryker
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.
Responsibilities
- 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
Requirements
- 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
Compensation: $89,300 - $148,800 USD Annual (USN) or $107,200 - $178,600 USD Annual (US20)
Vacancy posted 25 days ago
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