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Stryker Validation Staff Engineer, Advanced Operations in Arroyo, Puerto Rico

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)

Who we want –

Self-directed imitators. 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.

Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What you will do –

Executes the innovation and development of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacture of new products.

Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.

Responsibilities:

  • 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.

  • Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.

  • Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.

  • Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.

  • Execute Process and Equipment Validations.

  • 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 MSA studies for new products and new processes. Provide training for manufacturing team members. Ensure adherence to GMP and safety procedures. Review and approval of validation documentation.

What you need –

  • Bachelor’s Degree.

  • Advanced English skills.

  • Previous experience in Medical Devices is mandatory.

  • Previous experience in Validation is mandatory.

  • Availability to work onsite in the Manufacturing Plant located in Arroyo.

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.

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