Senior Process Engineer, Advanced Operations

Work Flexibility: Hybrid

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

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.