Position Summary

Join the Product Transfer Team as Staff Engineer, to be the Subject Matter Expert across several engineering competencies including Lean Six Sigma, manufacturing and automation. The Staff Engineer will provide technical leadership in the newest, greenfield Stryker facility.

What will you 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. 

• Determine the technical objectives of engineering assignments and make decisions regarding the direction and the results of the assignment.  

• Ensure application of engineering principles and the appropriate use of policies and procedures.  

• Lead capital acquisition activity 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.  

• Ensure quality of process and product as defined in the appropriate operation and material specifications.

• 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. 

• Complete capability studies for in process inspection and generate subsequent Inspection documentation.   

• Conduct MSA (Measurement Systems Analysis) and Capability Studies for transferred equipment. 

What you need:

Required:

• Experience with Equipment Purchase and commissioning

• 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.

• Excellent analytical skills, ability to plan, organize and implement concurrent tasks.

• Working knowledge of manufacturing processes (especially metal machining/turning/milling and associated finishing processes), product/process design and engineering materials.

• Experience of MES/SAP, GD&T (Geometric dimensioning and tolerancing), Process Mapping, statistical methods, production indicators and process/ product validations is desirable.

Preferred:

• Certified in validation activities.

• Green Belt 6 Sigma qualifications are an advantage.

• CAD Programs use in practice

• Experience in an FDA (Food and Drug Administration) regulated or MedTech Devices industry.