Hybrid Staff Engineer, Process Development

at Stryker

• Job title: Staff Engineer, Process Development
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Tempe, United States

About the role

• Staff Engineer focusing on engineering support for cleaning process in the manufacturing space at Stryker. Involve in new product introduction, process validation, and compliance with quality standards.

Responsibilities

• 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