Job Description

What you will do:

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.

What You Need:

• Bachelors Degree, required
• 2+ years of relevant experience, required
• Experience with process and fixture development
• Experience working with suppliers

Preferred Qualifications:

• Bachelors in Engineering
• 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.

$100,400 - $160,800salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

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