NPI Engineer

Alpfa Medical, Palo Alto California

• We are a fast-paced medical device organization developing innovative catheter-based therapeutic solutions for unmet and under-addressed needs in urology and other specialties. Our growing product pipeline brings together R&D, Manufacturing Engineering, Supply Chain, Quality, Clinical, and Manufacturing teams to turn promising prototypes into safe, scalable products.
• We value practical innovation: applying disciplined Design Control, Design for Excellence, and data-driven process development to create reliable manufacturing processes that meet end-user needs while enabling timely delivery. Our culture emphasizes cross-functional partnership, psychological safety, thoughtful risk-taking, and a shared commitment to doing more, better, and faster.

Why ALPFA?

• This is an opportunity to do consequential work: helping bring novel catheter-based therapies to patients with unmet or under-addressed needs in urology and other specialties.
• You will have real ownership in a foundational role—turning promising R&D concepts into reliable, scalable products and helping establish the NPI transfer model for a growing product portfolio. Your work will be visible, practical, and directly connected to patient impact.
• Whether you are energized by solving hard technical problems, building systems from the ground up, collaborating across disciplines, growing into broader operations leadership, or being recognized and rewarded for exceptional results, this role offers room to make a meaningful contribution.
• You will work with an experienced leadership team and gain broad operational exposure across product development, supply chain, manufacturing, sterilization validation, facility moves, and cleanroom qualification. We offer meaningful growth, opportunities to lead future transitions, and competitive equity and financial rewards.

Position Summary

The NPI Engineer will lead the transfer of novel catheter products from R&D prototypes into scalable pilot-line and clinical manufacturing. This role builds repeatable, reproducible, and operator-independent manufacturing processes while balancing near-term program execution with long-term product and operational scalability.

The ideal candidate is a hands-on engineer with strong design-for-manufacturing judgment, experience with catheter or similar medical-device processes, and the ability to align R&D, Supply Chain, Quality, Clinical, and Manufacturing Engineering around practical, data driven decisions.

What You’ll Do

• Lead NPI transfer activities from R&D prototyping through pilot-line and clinical manufacturing readiness.
• Apply Design for Manufacturing (DFM) and Design for Excellence (DFX) principles early in development to improve manufacturability, sterilization of readiness, process robustness, and scalability.
• Partner with R&D to assess prototype designs and down-select catheter configurations that meet end-user requirements and can be manufactured reliably.
• Collaborate with Supply Chain to define sourcing strategies and maximize use of qualified suppliers
• Work with Manufacturing Engineering and Mfg. Operators to develop, document, and improve repeatable, reproducible, and scalable catheter manufacturing processes.
• Use DOE, lean process-development tools, and structured problem-solving to establish process capability and reduce dependence on individual operator skill.
• Map current DDP and Design Control practices, identify gaps, and help establish a robust NPI transfer model for the future catheter product portfolio.
• Communicate priorities clearly; influence cross-functional decisions; and balance schedule, business, quality, and long-term manufacturability needs.
• Foster a collaborative, psychologically safe environment that promotes knowledge sharing, practical problem solving, and accountability.

What You Bring

• Bachelor’s degree in mechanical, Manufacturing, Biomedical, Materials, Chemical, or a related engineering discipline
• 7+ years of experience in medical-device product development, NPI, manufacturing engineering, or process development; or an equivalent combination of education and directly relevant experience.
• Direct catheter, delivery system, or minimally invasive device experience is strongly preferred; candidates with comparable complex disposable-device or precision-assembly experience are encouraged to apply.
• Hands-on experience developing, transferring, or scaling manufacturing processes for catheter or comparable medical-device products.
• Strong working knowledge of DFM, DFX, Design Control, DDP, process validation concepts, and NPI transfer practices.
• Demonstrated ability to translate prototype-stage designs into stable manufacturing processes that perform consistently across operators and normal process variation.
• Experience working effectively across R&D, Quality, Supply Chain, Clinical, Manufacturing Engineering, and Manufacturing.
• Familiarity with supplier selection, supplier qualification, second-source planning, and supply-continuity risk management.
• Ability to use data, DOE, lean methods, and structured problem solving to guide technical decisions and tradeoffs.
• Strong planning, communication, organization, and influence skills in a fast-paced environment.
• A collaborative leadership style that creates alignment without compromising product, quality, or end-user requirements.