Senior Staff Engineer, Advanced Operations

3 weeks ago

Cork, Cork, Ireland Stryker Group Full time

Senior Staff Engineer – Process Development, Advanced Operations Reports To: Manager – Advanced Operations

Key Areas of Responsibility Determine the technical objectives of engineering assignments and make decisions regarding the direction and results of the assignment. Monitor and control progress of work, ensuring sound application of engineering principles and policies. Lead capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation. Analyze equipment to establish operating data, conduct experimental tests, and analyze results.
May lead or serve as an independent reviewer in process review meetings. Coach and mentor team members on related topics. Provide engineering support for new product and process introductions, ensuring activities are completed and documented per Stryker procedures. Ensure quality of process and product as per operational and material specifications. Select components and equipment based on specifications, reliability, and regulatory requirements; collaborate with quality engineers to develop testing and inspection protocols. Participate in PFMEA, Control Plan, SOP, and PPAP generation related to product transfers and launches. Ensure adherence to GMP and safety procedures. Review and approve validation documentation. Perform all other duties as assigned. Qualifications, Knowledge, Skills B.S.
in Mechanical Engineering or related field with 6+ years of experience; Master's degree with 2+ years or PhD may be desirable. Proven experience working in a team environment. Excellent interpersonal skills for effective collaboration with multidisciplinary teams. Innovative thinker with the ability to envisage new and improved methods. Experience in complex problem-solving related to manufacturing and design issues. Good understanding of Design for Manufacturing (DFM), statistical tools, and validation/verification techniques. Strong analytical skills with the ability to plan, organize, and execute concurrent tasks. Excellent knowledge of manufacturing processes, product and process design, and engineering materials. Ability to read and interpret complex engineering drawings, including geometrical dimensioning and tolerancing. Certification in validation activities. Green or Black Belt in Six Sigma is an advantage. Experience in FDA-regulated industries is beneficial. High proficiency in PC skills. Exceptional attention to detail. Stryker is a global leader in medical technologies, committed to improving healthcare outcomes through innovative products and services across MedSurg, Neurotechnology, Orthopaedics, and Spine.
We impact over 150 million patients annually worldwide.

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