New Product Introduction Manager

About the Company

ENvue Medical is building a next-generation enteral access platform, focused on improving how clinicians safely establish and use access to the gastrointestinal tract. The company is assembling a broad and growing portfolio of enteral access solutions that support the delivery of nutrition, medications, and fluids across hospital and home-care settings. At the core of ENvue’s platform are advanced bedside technologies designed to improve visibility, confidence, and consistency during enteral access procedures, while addressing one of the most common processes in patient care. By expanding beyond a single product into a broader access-focused portfolio, ENvue is shaping the future of enteral access across the continuum of care. ENvue Medical is a publicly traded medical device company that includes ENvue as its growth platform. Alongside this platform, ENvue Medical operates established urology and pain management franchises within the same public company structure. With an expanding presence in U.S. hospitals and a clear strategy to grow through innovation and targeted acquisitions within enteral access, ENvue offers the opportunity to join a team building a category-defining medical device platform at a meaningful stage of growth.

About the Role

As NPI Manager, you will be the operational engine behind ENvue's new product launches - bridging R&D, Operations, and Product leadership to bring advanced bedside capital equipment and disposables from development into successful production. Reporting to the VP Product and collaborating closely with R&D and Operations teams in Tel Aviv and the Operations team in Plymouth, Minnesota, you will own the NPI process end-to-end and ensure every product reaches the market on time, on cost, and to the quality standards expected in a clinical environment.

Responsibilities

• Own and drive the full NPI lifecycle for ENvue's capital equipment and instrument programs - from design freeze and design transfer through pilot builds, verification, and production ramp.
• Serve as the primary cross-functional coordinator between R&D (Tel Aviv), Operations (Tel Aviv & Plymouth, MN), and the VP Product, ensuring alignment on milestones, priorities, and launch readiness.
• Develop and maintain detailed NPI project plans, phase gate schedules, and risk logs; proactively surface and resolve issues before they impact timelines.
• Lead design transfer activities, ensuring all manufacturing documentation such as BOMs, work instructions, and test procedures, is complete, accurate, and production-ready across both sites.
• Coordinate reviews with engineering to optimize products for manufacturability and testability at Tel Aviv and Plymouth, MN.
• Manage prototype builds and pilot production runs, tracking open issues and driving them to closure across geographically distributed teams.
• Partner with supply chain and procurement on component qualification, supplier readiness, and long-lead item management.
• Support quality activities including PFMEA, control plans, IQ/OQ/PQ, and DHF/DMR documentation in line with ISO 13485 and applicable regulatory requirements.
• Capture lessons learned after each launch and drive continuous improvement to ENvue's NPI process as the portfolio expands.

Qualifications

• Bachelor's degree in Engineering, Industrial Engineering or a related field.
• 4–7 years of experience in NPI, manufacturing engineering, or product launch roles in medical devices.
• Solid understanding of capital equipment development and production processes.
• Familiarity with medical device quality systems: FDA, ISO 13485, design transfer, DHF/DMR, and V&V processes.
• Experience coordinating across multi-site or international teams.
• Hands-on and detail-oriented, with the ability to work independently as an individual contributor and manage competing priorities across a growing product portfolio.
• Excellent communication skills in English and Hebrew.
• Proficiency with ERP systems and project management tools (e.g., Smartsheet, MS Project, Jira).

Required Skills

• Ownership and accountability
• Hands-on execution mindset
• Ability to work in a fast-growing environment
• Collaboration across global teams
• Commitment to quality and patient safety

Preferred Skills

• Work on technology that improves patient safety
• Join a growing Nasdaq-listed medical device company
• High-impact role in a small, execution-focused team
• Opportunity to grow with the organization