Stryker · 1 day ago
Staff Engineer, Process Development – Cleaning
Tempe, Arizona
Full-time
Hybrid
Senior Level, Lead/Staff
4+ years expStryker’s Sustainability Solutions Advanced Operations team is seeking to hire a Staff Engineer, Process Development – Cleaning to work on new product introduction process development. This role focuses on the cleaning aspects of reprocessing and involves providing engineering support for new product and process introductions, ensuring quality, and leading cross-functional teams.
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
Drive and execute effective communication with all stakeholders to enable project success
Select components and equipment based on analysis of specifications, reliability, and regulatory requirements
Lead/support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation
Lead/participate in process review meetings
Analyze equipment to establish operating data, conduct experimental test and result analysis and participate in process review meetings
Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches
Complete capability studies for process inspection and generate subsequent Inspection documentation
Conduct qualifications, 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
Provide training for manufacturing team members
Ensure adherence to GMP and safety procedures. Ensure adherence to GDP, write MAPs/PPMs. Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals
Conduct RCA, DOE, and result analysis, analyze cleaning equipment to establish operating data
Serve as a subject matter expert in cleaning methodologies and process development
Provide expertise in cleaning agent selection, cleaning process technologies, and cleaning process optimization
Work with New Product/Process Development, New Product/Process Introduction cross-functional team including quality and R&D engineers to develop component specific testing and inspection protocols
Understand and lead DFM, Identify and lead Cleaning Process/Equipment Initiatives
All other duties as assigned
Qualification
Required
Engineering or Technical Bachelors Degree required. Chemical Engineering degree preferred
4+ years' relevant work experience
Experience in executing complex problem solving techniques related to manufacturing/design technical issues
Knowledge of manufacturing processes, materials, product, and process design. Strong understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques
Experience in new production introduction or manufacturing engineering
Experience with fluid dynamics and hydraulic calculations as well as air and vacuum drying
Preferred
Strong communication skills with the ability to effectively work cross-functionally and externally as required
Experience with PLC/Ladder Logic and other programming software
Experience in an FDA regulated or regulated industry preferred
Experience with cleaning processes, cleaning system design, cleaning equipment, and cleaning chemicals relating to medical device reprocessing including flushing, sonication, spraying, washing, rinsing, and drying
Experience with water systems including Soft Water, RO and RODI
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