Senior NPD Manufacturing Engineer

As a Senior NPD Manufacturing Engineer, you will support the design transfer of products from R&D to Service. In this role, you will collaborate with cross-functional teams in both technical and non-technical capacities to successfully launch servicing of new products. You will also be responsible for developing and qualifying the repair process for medical devices at Stryker.

• Use latest engineering techniques to provide design and process inputs for serviceability whilst adhering to regulatory requirements, project deadlines and product costs.

• Analyze, determine, and advocate for service model that best meets the needs of our customers and business.

• With minimal guidance determine and develop approaches to a variety of technical problems of complex scope and complexity.

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

• Lead engineer for launching servicing of new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product and service development procedures.

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

• Provide input on components and equipment based on analysis of specifications, reliability and servicing requirements. Work with quality engineers to develop component specific testing and inspection protocols.

• Analyze equipment and process to establish servicing parameters and criteria. Lead and/or participate in process review meetings.

• Participate in PFMEA, Control Plan, SOP and PPAP generation associated with service product transfers and launches.

• Execute, review and approve complex validation of new equipment or new processes.

• Introduce new service manufacturing technology and service commercial offerings

• Work closely with service sustaining to transfer engineering test procedures to manufacturing test procedures 

• Ensure adherence to GMP and safety procedures.

Minimum Requirements:

• Bachelor’s Degree in Engineering

• 2+ years of relevant experience

• Experience with process and fixture development

• Experience working with suppliers

Preferred Qualifications:

• Knowledge of applicable domestic and international regulations and quality system standards – FDA QSR, MDD, ISO13485, ISO9001, etc.

• Experience in independently executing moderately complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.

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

• Proven ability to handle multiple assignments at once while meeting all deadlines

• Must be able to routinely make decisions which affect immediate operations.

• Demonstrated ability to plan, track and facilitate projects.

• Preferred understanding of Quality Management System tools, Six Sigma tools, problem solving, root cause analysis, Lean and continuous improvement methodologies, with proven ability to apply them.