Skawina, POL
2 days ago
Senior Engineer, Product Transfer
We are seeking a detail-oriented Engineer to Product Transfer team to execute the seamless transfer of products with technology between production sites. The ideal candidate will coordinate cross-functional teams to ensure transfers are executed on time, within budget, and meet all quality and regulatory standards. This role involves overseeing process validation, updating documentation, troubleshooting transfer issues, and facilitating training to support manufacturing readiness and compliance. **What you will do** + Provide engineering support for product transfer and process introductions, ensuring that all activities are completed and documented in accordance with the latest Stryker procedures. + Determines the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment. + Will ensure application of engineering principles and the appropriate use of policies and procedures. + Will work on capital acquisition from specifying equipment, contract negotiation, Installation, and validation. + Will analyze equipment to establish operating data, conduct experimental tests and result analysis. May lead or act as independent reviewer in process review meetings. + Conduct FAT and SAT runs and will lead commissioning activities to release equipment with validated process to serial production. + Provide engineering support for product transfer and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures. + Will purchase, commission, setup, validate production equipment and prepare work instructions together with operator trainings. + Ensure quality of process and product as defined in the appropriate operation and material specifications. + Will select components and equipment based on analysis of specifications, reliability, and regulatory requirements. + Perform Cp/Cpk studies as well as conduct MSA. + Participate in PFMEA (Process Failure Mode and Effect Analysis), Control Plan, SOP (Start of Production) and PPAP (Production Part Approval Process) (Stryker internal process qualification generation associated with product transfers and launches). + Will be responsible to create Inspection Guide Sheets per PCP and complete process routing within SAP/MES environment. + Ensure adherence to GMP (Good Manufacturing Practices) and safety procedures. + Create, Review and Execute validation documentation within latest STRYKER procedures. + Conduct MSA (Measurement Systems Analysis) and Capability Studies for transferred equipment. + Provide training to manufacturing team members. **What you must have (preferred but not limited to)** + Experience with Equipment Purchase and commissioning + Working knowledge of manufacturing processes (especially metal machining/turning/milling and associated finishing processes), product/process design and engineering materials. + Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Engineering data based analytical approach for mechanical, automation and structural design. + Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques. + Must be able to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing. + Practical knowledge in Validation (IQ, EQ, OQ_P, PQ) will be beneficial + CAD Programs use in practice + Experience of MES/SAP, GD&T (Geometric dimensioning and tolerancing), + Will provision: Experience in an FDA (Food and Drug Administration) regulated or MedTech Devices industry + Skilled in data analysis and familiar with statistical terms: Normal Distribution, Range, Mean, Standard Deviation, Capability + Skilled in Measurement System Analysis + Capable of creating Process Documents like PFMEA, PCP, Work Instruction, Setup Sheets + Excellent presentation and written / verbal communication skills Qualifications + B.S in Mechanical Engineering or related engineering discipline + 3- -5 years experience + Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment + Must Speak Polish and English Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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. 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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