Senior Engineer Product Transfer
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Currently we are looking for engineers to join our Product Transfer team supporting our first Mega Site in Stryker. If you have education or experience with machining, fabrication, surface treatment, cleaning, chemical processes (like but not limited to: degreasing, vapor treatment, electro polishing) and willing to join STRYKER team, please apply. Start the process today and don’t give up. If you have experience in regulated industries like the food, electronics, and automotive industry. We are looking for you, different skills will strengthen our Team.
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.
- 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.
- 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.
- 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).
- 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:
- 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),
- 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.