Senior Operations Engineer
hace 1 semana
About the Role
Stryker is seeking a highly skilled Senior Operations Engineer to join our Advanced Operations team in Tijuana, Mexico. As a key member of our team, you will be responsible for providing engineering support and leadership for product and process introductions, ensuring that all activities are completed and documented in accordance with Stryker's product procedures.
Key Responsibilities
- Collaborate with global sites to lead design transfer activities for new product launches into the Tijuana manufacturing plant.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements.
- Support capital acquisition activities.
- Analyze equipment to establish operating data, conduct experimental tests, and result analysis, and participate in process review meetings.
- Participate in PFMEA, Control Plan, SOP, and PPAP generation associated with product launches.
- Complete capability studies for in-process inspection and generate subsequent Inspection documentation.
- Conduct validation and MSA studies for new products and new processes.
- Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development.
- Author, review, and approve validation documentation.
- Drive and execute effective communication with all stakeholders to enable project success.
- Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology.
- Lead creation and refinement of engineering documentation.
- Provide training for manufacturing team members.
- Ensure adherence to good manufacturing practices (GMP) and safety procedures.
Requirements
- Bachelor's degree in Engineering or related field required.
- 2+ years of relevant work experience required.
- Bilingual fluency (English & Spanish) required.
- OnePLM and Valgenesis experience highly preferred.
- Good knowledge of manufacturing processes, materials, product, and process design preferred.
- Experience with engineering development, including installation qualification, operational qualification, performance qualification (IQ/OQ/PQ), or equivalent experience.
- Leading and coordinating team efforts through projects preferred.
- Experience in a FDA regulated or medical device and/or biotech field preferred.
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