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Stryker

Stryker

via Indeed

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Senior NPD Manufacturing Engineer

Anywhere
full-time
Posted 8/27/2025
Verified Source
Key Skills:
Process and fixture development
Supplier collaboration
Manufacturing design transfer
Regulatory knowledge (FDA QSR, MDD, ISO13485, ISO9001)
Problem solving
Quality Management System tools
Six Sigma
Lean and continuous improvement

Compensation

Salary Range

$100K - 161K a year

Responsibilities

Lead design transfer and servicing process development for new medical device products, ensuring quality and regulatory compliance.

Requirements

Bachelor's degree, 2+ years relevant manufacturing engineering experience, process and fixture development skills, supplier experience, and preferred knowledge of quality and regulatory standards.

Full 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: • Bachelor’s Degree, required • 2+ years of relevant experience, required • Experience with process and fixture development • Experience working with suppliers Preferred Qualifications: • Bachelor’s 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 - $160,800 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

This job posting was last updated on 9/2/2025

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