Stryker Group
Stryker’s Sustainability Solutions Advanced Operations team is seeking to hire a Senior Process Engineer, Advanced Operations to work on new product introduction process development in Tempe, AZ. This role supports the execution of assigned project elements with an emphasis on the manufacturing process, technology, and procedures required for the manufacture of new products.
What you will do
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
Assist in the selection and design of equipment based on analysis of specifications, reliability, and regulatory requirements, with a focus on identifying opportunities for automation to improve efficiency, improve capacity, and/or reduce product cost
Ensure quality of process and product as defined in the appropriate operation and material specifications
Support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation
Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals
Analyze equipment to establish operating data and conduct experimental test and result analysis
Use engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs
Participate in process review meetings
Participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches
Complete capability studies for in-process inspection and generate subsequent inspection documentation
Conduct qualifications, validations, and measurement system analysis (MSA) studies for new products and new processes. Review and approve validation documentation
Work in a hands‑on manner at the manufacturing site to support the implementation of new processes as specified in development
Drive and execute effective communication with all stakeholders to enable project success
Provide training for manufacturing team members
Ensure adherence to GMP and safety procedures
What you need
2+ years of relevant work experience – required
Bachelor’s degree in engineering – required
Bachelor's degree in Electrical Engineering – highly preferred
Experience with programmable logic controllers (PLC), ladder logic, and/or other similar programming languages – highly preferred
Understanding of control system wiring and wiring diagrams – highly preferred
Lean Six Sigma Green Belt Certification or above – preferred
Knowledge of manufacturing processes, materials, product, and process design – preferred
Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques – preferred
Experience writing and executing validations – preferred
Experience in new product introduction or manufacturing engineering – preferred
Experience in an FDA regulated or regulated industry – preferred
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What you will do
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
Assist in the selection and design of equipment based on analysis of specifications, reliability, and regulatory requirements, with a focus on identifying opportunities for automation to improve efficiency, improve capacity, and/or reduce product cost
Ensure quality of process and product as defined in the appropriate operation and material specifications
Support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation
Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals
Analyze equipment to establish operating data and conduct experimental test and result analysis
Use engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs
Participate in process review meetings
Participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches
Complete capability studies for in-process inspection and generate subsequent inspection documentation
Conduct qualifications, validations, and measurement system analysis (MSA) studies for new products and new processes. Review and approve validation documentation
Work in a hands‑on manner at the manufacturing site to support the implementation of new processes as specified in development
Drive and execute effective communication with all stakeholders to enable project success
Provide training for manufacturing team members
Ensure adherence to GMP and safety procedures
What you need
2+ years of relevant work experience – required
Bachelor’s degree in engineering – required
Bachelor's degree in Electrical Engineering – highly preferred
Experience with programmable logic controllers (PLC), ladder logic, and/or other similar programming languages – highly preferred
Understanding of control system wiring and wiring diagrams – highly preferred
Lean Six Sigma Green Belt Certification or above – preferred
Knowledge of manufacturing processes, materials, product, and process design – preferred
Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques – preferred
Experience writing and executing validations – preferred
Experience in new product introduction or manufacturing engineering – preferred
Experience in an FDA regulated or regulated industry – preferred
#J-18808-Ljbffr