Senior Technical Operations Specialist
hace 4 semanas
**About the Role**
We are seeking a highly skilled Senior Technical Operations Specialist to join our team at Stryker Corporation. As a key member of our Advanced Operations team, you will be responsible for independently determining and developing approaches to technical problems of moderate scope and complexity.
**Key Responsibilities**
- Provide 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.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Lead and/or participate in process review meetings, analyze equipment to establish operating data, conduct experimental tests, and result analysis.
- Participate in PFMEA, Control Plan, SOP, and PPAP generation associated with product transfers and launches.
- Complete capability studies for in-process inspection and generate subsequent inspection documentation.
- Conduct MSA studies for new products and new processes.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
- Review and approval of validation documentation.
**Requirements**
- B.S. in Mechanical Engineering or related engineering discipline.
- 5 years' experience.
- Excellent interpersonal skills, able to express ideas and collaborate effectively with multidisciplinary teams.
- Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.
- Good instincts and sound judgment for mechanical and structural design.
- Good understanding of Design for Manufacturing (DFM), related statistical tools, and validation/verification techniques.
- Excellent analytical skills, ability to plan, organize, and implement concurrent tasks.
- Good knowledge of manufacturing processes, materials, product, and process design.
- Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Certified in validation activities.
- Experience in an FDA-regulated or regulated industry beneficial.
- High level of PC skills required.
- Excellent attention to detail.
- Bilingual in English and Spanish.
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