Senior Process Engineer, Advanced Operations (AO)
stryker · Portage
Job description
About the role
Stryker's Advanced Operations (AO) team is looking for a Senior Process Engineer to support the introduction of new products and manufacturing processes. The role provides process engineering expertise across product launches, transfers, equipment validation and manufacturing readiness, working with cross-functional teams to build scalable, efficient and compliant manufacturing solutions. Work is onsite.
Key responsibilities
- Lead process engineering for new product introductions and process transfers, following established development procedures.
- Develop, implement and maintain manufacturing processes that meet operational, material and regulatory specifications.
- Select equipment and components based on technical requirements, reliability analysis and regulatory standards.
- Run process validation activities including PFMEA, control plans, SOPs, PPAP documentation, capability studies and MSA.
- Analyze process and equipment performance through testing, data collection and statistical evaluation to support continuous improvement.
- Support capital equipment acquisition, including specification, vendor coordination, installation, qualification and validation.
- Review and approve validation and quality documentation in line with GMP and safety requirements.
- Train manufacturing personnel and guide them during product launches, process implementation and scale-up.
Required profile
- Bachelor's degree in Mechanical Engineering or a related engineering discipline.
- At least 2 years of experience in manufacturing, process engineering, product development or R&D.
- Experience with manufacturing processes, materials, product design or process design.
- Ability to read and interpret engineering drawings and technical specifications.
- Preferred: regulated industry experience (medical devices, pharmaceuticals, aerospace), process validation support, DFM knowledge, statistical analysis tools and structured problem-solving experience.
What we offer
- Salary of $77,700 - $129,500 USD per year.
- 10% travel allowance.
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Published 4 days ago
Expires 1 month from now
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stryker
Portage