Staff Engineer, Process Development – Cleaning

Stryker•Minooka, IL

1d•Hybrid

About The Position

Stryker’s Sustainability Solutions Advanced Operations team is seeking to hire a Staff Engineer, Process Development – Cleaning to work on new product introduction process development across our sites in the greater Phoenix area (Phoenix, Chandler, Tempe). This role supports the execution of assigned project elements with an emphasis on the manufacturing process, technology, and documentation required for the manufacture of new products. This role is focused on the cleaning aspects of reprocessing including flushing, sonicating, spraying, washing, rinsing, and drying. What You Will Do The Staff Engineer will independently determine and develop approaches to a variety of technical problems of moderate scope and complexity with an emphasis on the equipment and process design for manufacturing, technology, and documentation required for the manufacture of new products. They will use the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs, and build productive internal and external working relationships. 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.

Nice To Haves

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.

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.