Senior Process Engineer, Advanced Operations
1 month ago
We are seeking a highly skilled Senior Process Engineer to join our Advanced Operations team. As a key member of our team, you will be responsible for providing engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with Stryker's new product development procedures.
Key responsibilities include:
- Providing engineering support for new product and process introductions
- Ensuring quality of process and product as defined in the appropriate operation and material specifications
- Selecting components and equipment based on analysis of specifications, reliability and regulatory requirements
- Leading/supporting capital acquisition activity from specifying equipment, contract negotiation, installation and validation
- Analyzing equipment to establish operating data and conducting experimental test and result analysis
- Leading process review meetings
- Leading PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches
- Completing capability studies for in-process inspection and generating subsequent inspection documentation
- Conducting process validation and MSA studies for new products and new processes
- Working in a hands-on manner at the manufacturing site to lead the implementation of new processes as specified in development
- Providing training for manufacturing team members
- Ensuring adherence to GMP and safety procedures
- Reviewing and approving validation documentation
Requirements include:
- Bachelor's degree in engineering required
- 2+ years of applicable work experience required
- Specialization or work experience in plastics or polymers
- Working knowledge of PFMEA required
- Excellent analytical skills, ability to plan, organize, and implement concurrent tasks
- Good knowledge of manufacturing processes, materials, product and process design
- Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T)
- CAD experience
Preferred skills include:
- Experience in R&D, new product development, or process design
- Injection molding process development experience
- Experience in an FDA regulated or regulated industry
- Experience with plastic assembly (e.g. adhesives, joining methods, welding)
- Ability to read and interpret complex engineering drawings and understand geometrical dimension and tolerances
- Experience in executing complex problem-solving techniques related to manufacturing/design technical issues
- Good understanding of Design for Manufacturing related statistical tools and validation/verification techniques
- CAD experience
- 3D printing experience
Stryker offers a comprehensive benefits package, including medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program. Financial benefits include a Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
Stryker is an equal opportunity employer and welcomes applications from qualified candidates without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
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