Senior Staff Engineer – Process Development, Advanced Operations
Reports To: Manager – Advanced Operations
Key Areas of Responsibility
1. Determine the technical objectives of engineering assignments and make decisions regarding the direction and results of the assignment.
2. Monitor and control progress of work, ensuring sound application of engineering principles and adherence to policies and procedures.
3. Lead capital acquisition activities, including specifying equipment, negotiating contracts, installation, and validation.
4. Analyze equipment to establish operating data, conduct experimental tests, and analyze results. May lead or serve as an independent reviewer in process review meetings.
5. Coach and mentor team members on functionally related topics.
6. Provide engineering support for new product and process introductions, ensuring activities are completed and documented per Stryker's new product development procedures.
7. Ensure quality of processes and products as defined by operational and material specifications.
8. Select components and equipment based on specifications, reliability, and regulatory requirements; collaborate with quality engineers on testing and inspection protocols.
9. Participate in PFMEA, Control Plan, SOP, and PPAP generation related to product transfers and launches.
10. Ensure adherence to GMP and safety procedures.
11. Review and approve validation documentation.
12. Perform all other duties as assigned.
Qualifications, Knowledge, and Skills
* B.S. in Mechanical Engineering or related field with 6+ years of experience; related master's degree with 2+ years of experience or PhD may be preferred.
* Proven experience working in team-based environments.
* Excellent interpersonal skills for effective collaboration across multidisciplinary teams.
* Innovative mindset with the ability to envision improved methods.
* Experience in complex problem-solving related to manufacturing and design issues, with good judgment in mechanical and structural design.
* Strong understanding of Design for Manufacturing (DFM), statistical tools, and validation/verification techniques.
* Excellent analytical, planning, and organizational skills.
* In-depth knowledge of manufacturing processes, product/process design, and engineering materials.
* Ability to read and interpret complex engineering drawings, including geometrical dimensioning and tolerancing.
* Certification in validation activities.
* Green or Black Belt in Six Sigma is advantageous.
* Experience in FDA-regulated or similar industries is beneficial.
* High proficiency in PC skills.
* Exceptional attention to detail.
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