Stryker · 23 hours ago
Staff Engineer, Advanced Operations
Portage, MI
Full-time
Onsite
Senior Level, Lead/Staff
4+ years expStryker is a company that offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine. They are seeking a Staff Engineer for Advanced Operations responsible for process design, development, and validation while collaborating with cross-functional teams during new product development. The role involves providing engineering support, ensuring quality, and analyzing equipment to meet regulatory requirements and project timelines.
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
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
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
Provide 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
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
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
Chief Executive Officer
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase