Engineer, Advanced Operations

Work Flexibility: Hybrid

Who we want:

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.

Stryker's Sustainability Solutions Advanced Operations team is seeking to hire an Engineer, Advanced Operations to work on new product introduction process development in Chandler, 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. This role is focused on the cleaning aspects of reprocessing including flushing, sonicating, spraying, washing, rinsing, and drying.

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.
• Assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements.
• Support capital acquisition activities.
• 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 in 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.
• Conduct 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.

What you need:

• Bachelor's Degree in Engineering or related engineering discipline or an analytical/physical chemistry degree required
• 1 year of relevant work experience- preferred
• Basic knowledge of manufacturing processes, materials, product, and process design- preferred
• Basic understanding of lean manufacturing principles and methodologies - preferred
• Ability to read and interpret complex engineering drawings and have understanding of geometrical dimensioning and tolerancing- preferred
• Experience in an FDA regulated or regulated industry - preferred
• Experience with cleaning processes, cleaning system design, cleaning equipment, and cleaning chemicals related to medical devices - preferred
• Experience with fluid dynamics including pipe sizing, pump sizing, hydraulic calculations, air and vacuum drying - preferred
• Experience with water systems including Soft Water, RO and RODI - preferred
• Experience with or knowledge of biological growth and removal, sampling, testing, and corrective action - 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.