Senior Mechanical Engineer

Location: Tel-Aviv

Work Model: On-site only

Reports To: COO/Director R&D

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

We are seeking an experienced Senior Mechanical Engineer who combines deep expertise in disposable medical device design with strong capabilities in complex electromechanical capital systems. This is a dual-domain role that spans the full product portfolio: from catheter-based disposables (enteral feeding tubes, guidewires, extrusion-based components) to the capital bedside system that enables ENvue's navigation technology. The ideal candidate brings hands-on expertise across both domains, is comfortable owning end-to-end design cycles, and thrives in a fast-moving, execution-oriented environment. This is a hands-on, on-site role that combines system-level engineering, design execution, supplier engagement, and cross-functional collaboration.

Responsibilities

Disposables

• Lead mechanical design of disposable components, including enteral feeding tubes, guidewires, connectors, and embedded navigation elements.
• Develop and optimize extruded tubing, including multi-lumen and specialty profiles, working with internal and external partners.
• Evaluate and source catheter materials, guidewire components, adhesives, coatings, and manufacturing technologies.
• Conduct tolerance analysis, material compatibility studies, and failure investigations.
• Support design for manufacturability (DFM), cost reduction, and supplier qualification activities.
• Participate in risk analysis, usability assessments, and Design History File (DHF) generation per ISO 13485 and FDA QSR.

Capital System

• Lead mechanical design of ENvue's capital system, including mechanical architecture, packaging, and structural integrity.
• Support continuous improvement of the current FDA-cleared platform in cost, manufacturability, reliability, and user experience.
• Collaborate with electrical, software, quality, clinical, and manufacturing teams to ensure system-level alignment.
• Work closely with external suppliers, contract manufacturers, and tooling partners.
• Participate in design reviews, risk assessments, and regulatory processes under ISO 13485 and FDA QSR.

Shared Responsibilities

• Generate and maintain 3D models, 2D drawings, BOMs, tolerance analyses, test protocols, and DHF documentation in compliance with regulatory standards.
• Drive full product development cycles: concept generation, prototyping, V&V, pilot production, and design transfer.
• Collaborate closely with clinical, regulatory, QA, operations, and external suppliers.

Qualifications

• BSc or MSc in Mechanical Engineering from an accredited institution.
• Minimum 10 years of experience in medical device development, spanning both disposable and capital/electromechanical systems.
• Proven experience with extrusion processes, catheter assembly, and guidewire-based components.
• Strong knowledge of biocompatible polymers (e.g. PU, Pebax, Nylon, TPE), bonding methods, and sterilization compatibility.
• Strong experience with plastics, metal components, DFM, and working with contract manufacturers.
• Expertise in SolidWorks (or equivalent CAD tool).
• Familiarity with design controls, DHF documentation, ISO 13485, FDA QSR, and medical device quality standards.
• Experience working with global suppliers and contract manufacturers.
• Excellent technical communication skills in English and Hebrew.

Preferred Skills

• Experience with Class II medical devices or capital bedside equipment.
• Exposure to EMC, thermal design, and mechanical integration of electronics.
• Comfort working in fast-paced, resource-conscious environments.