• Staff Process Engineer, Advanced Operations

    Stryker (Tempe, AZ)


    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

    + 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

    + Assist in the selection of 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

    + Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals

    + Analyze equipment to establish operating data and conduct experimental test and result analysis

    + Lead/participate in process review meetings

    + Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches

    + Complete capability studies for in-process inspection and generate subsequent inspection documentation

    + Conduct qualifications, validations, and 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

    + Provide training for manufacturing team members

    + Ensure adherence to GMP and safety procedures

    What you need-

    + 4+ years of relevant work experience – required

    + Bachelor's Degree in Engineering – required

    + Bachelor's degree in Industrial or Systems Engineering - 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

    + Ability to read and interpret complex engineering drawings and have understanding of geometrical dimensioning and tolerancing – preferred

    + Experience writing and executing validations – preferred

    + Experience in new production 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.