Schedule:

Monday – Friday, 7:30AM – 4:30 PM (Flexibility based on project needs)

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About Us:

‍Sincera Talent Partners is working with an innovative medical device manufacturer in Phoenix, AZ, seeking a New Product Introduction (NPI) Engineer to bridge the gap between product development and full-scale manufacturing. In this role, you will play acritical part in ensuring medical innovations are seamlessly transitioned into production while meeting FDA, ISO 13485, and GMP standards.

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Who You Are:

‍A hands-on problem solver with a deep understanding of manufacturing process validation, design transfer, and regulatory compliance. You thrive in fast-paced, highly regulated environments and enjoy collaborating with cross-functional teams to ensure smooth product launches.

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What You’ll Do:

• ‍Lead NPI Processes: Own the transition of new medical devices from R&D to production, ensuring manufacturability, cost-efficiency, and scalability.
• ‍Process Validation & Compliance: Develop and execute IQ, OQ, PQ validation protocols to establish stable manufacturing processes.
• ‍Optimize Design for Manufacturing (DFM / DFA): Collaborate with design engineers to refine products for high-yield, cost-effective production.
• ‍Cross-Functional Collaboration: Work closely with Quality, Regulatory, Supply Chain, and Operations to align product launches with industry and company standards.
• ‍Risk Management & Continuous Improvement: Identify potential process risks (FMEA) and drive data-driven improvements.
• ‍Supplier & Vendor Integration: Assist in qualifying new materials, tooling, and suppliers to ensure supply chain readiness.

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Must-Have Qualifications:

• ‍3+ years of experience in NPI, process engineering, or manufacturing engineering within the medical device or regulated industries.
• Expertise in ISO 13485, FDA 21 CFR Part 820, and GMP requirements.
• Hands-on experience with process validation (IQ, OQ, PQ), DOE, and risk analysis (FMEA, PFMEA).
• Strong knowledge of medical-grade materials, machining, injection molding, and automated assembly.
• Ability to collaborate across engineering, quality, regulatory, and manufacturing teams to drive project success.
• ‍Excellent problem-solving and documentation skills, with the ability to communicate complex data effectively.

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What We Offer (Benefits & Culture):

• ‍Competitive Salary + Performance Bonuses
• 401(k) Matching & Comprehensive Health Benefits
• Paid Time Off + Flexible Work Arrangements
• Career Development, Tuition Reimbursement, and Certification Support
• Diverse& Inclusive Workplace with Employee Resource Groups (ERGs)

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We believe diversity drives innovation. If you’re passionate about bringing cutting-edge medical devices to life through smart engineering and collaboration, we’d love to hear from you!

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Sincera Talent Partners is dedicated to fostering a diverse and inclusive environment. We are proud to be an equal opportunity employer, and we only partner with companies that share our commitment to diversity, equity, and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are committed to creating a workplace that values and respects individuals from all backgrounds and experiences.

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