Senior Process Engineer, Advanced Operations

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

Health benefits include : Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include : Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.