Staff Engineer, Product Transfer

Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity.

Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.

Builds productive internal and external working relationships and may periodically provide guidance and train other team members.

• Provide engineering support for product transfer and process introductions, ensuring that all activities are completed and documented in accordance with the latest Stryker procedures.

• May Lead technical expertise, set directions, and inspire other team members within project team.

• 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.

• 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.

• 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.

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

• 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..

• Experienced working in a team-based environment.

• Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Receptive to new perspectives and capable of identifying valuable concepts.

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

• 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.

• Certified in validation activities.

• Demonstrable strong analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced environment .

• Demonstrable ability to work autonomously.

• 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. (P)

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

• Skilled in data analysis and familiar with statistical terms: Normal Distribution, Range, Mean, Standard Deviation, Capability.

• Capable of creating Process Documents like PFMEA, PCP (Process Control Plans), Work Instruction, Setup Sheets

• Excellent presentation and written / verbal communication skills