Staff Engineer, Process Development
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Tempe • Arizona • United States
Visit company websiteExplore more
Job Level
About the role
- Determine and develop approaches to a variety of technical problems of moderate scope and complexity
- 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.
Requirements
- 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.
- 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.
Benefits
- Work Flexibility: Hybrid
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
problem solvingmanufacturing processesproduct designprocess designDesign for Manufacturing (DFM)statistical toolsvalidation techniquesfluid dynamicshydraulic calculationscleaning process optimization
Soft skills
communicationcross-functional collaborationleadershiptraining
Certifications
Engineering degreeChemical Engineering degree