Stryker · 1 month ago
Staff Engineer, Advanced Operations
Portage, Michigan
Full-time
Hybrid
Senior Level, Lead/Staff
4+ years expStryker is a leading medical technology company, and they are seeking a Staff Engineer for Advanced Operations. This role is responsible for process design, development, and validation while collaborating with cross-functional teams to ensure quality and compliance in new product development.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures
Ensure quality of process and product as defined in the appropriate operation and material specifications
Will select components and equipment based on analysis of specifications, reliability and regulatory requirements
May lead/support capital acquisition activity from specifying equipment, contract negotiation, installation and validation
Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings
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
Provides on-going status reports including periodic reviews progress and evaluation of results to management
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
Must be able to generate, follow and explain detailed proposals and operating procedures (i.e. assembly instructions, inspection procedures, and capital project proposals)
Must be able to analyze and correct complex product and/or process issues using independent judgement
Must be able to routinely make decisions that affect immediate operations
Must be able to plan, organize, and implement multiple concurrent tasks
Qualification
Required
Bachelor's Degree in Engineering (Mechanical, Biomedical, Electrical Engineering preferred)
4+ years related years of experience
Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design
Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques
Good knowledge of manufacturing processes, materials, product and process design
Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerancing
Preferred
Experience in an FDA regulated or regulated industry preferred
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase