Validation Staff Engineer, Advanced Operations

2 maanden geleden


Best, Noord-Brabant, Nederland Stryker Voltijd

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.


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