Research Development Mechanical Engineer

Company Description

Premia Spine is revolutionizing the treatment of debilitating leg and back pain with the innovative TOPS™ System, the first-of-its-kind facet joint replacement solution. TOPS™ is the only novel, non-fusion motion preservation solution for treating patients with major lumbar diseases, including degenerative spondylolisthesis and spinal stenosis. Premia Spine is dedicated to developing advanced medical technologies. The TOPS™ System is designed to improve the quality of life for patients, making a significant impact in the field of spinal healthcare.

Role Description

This is a full-time, on-site position for an R&D Mechanical Engineer based in Netanya, Israel. The R&D Mechanical Engineer will be responsible for designing and developing surgical instruments, including creating new tools based on surgeon input and improving existing designs to enhance performance, usability, and manufacturability.

The role combines hands-on engineering work with extensive documentation in a regulated medical device environment. Responsibilities include laboratory testing, prototype evaluation, and execution of development and verification activities, alongside preparation of protocols, reports, and design documentation throughout the product lifecycle.

This position requires hands-on experience with manufacturing processes such as CNC machining, EDM, laser welding, and related technologies. Prior experience in the medical device industry and familiarity with working in a regulated environment are mandatory.

Job Requirements:

• B.Sc. in Mechanical Engineering
• Proficient in Solidworks
• Minimum of 3 years of proven experience in the medical device industry (mandatory) as an R&D Engineer
• Proven experience with product design under design control process and DHF management.
• Experience working with ECOs and MRBs in a regulated environment
• Experience in planning, writing, and executing verification tests, including laboratory testing and prototype evaluations
• Practical experience with manufacturing technologies (e.g., CNC, EDM, lathe, etc.)
• Strong problem-solving skills with a practical, production-oriented mindset
• Ability to work cross-functionally with R&D, manufacturing, quality, and clinical teams
• Willingness to travel occasionally for supplier visits and surgical support
• Proficiency in both spoken and written English.

Job Description & Responsibilities:

• Design and develop new surgical instruments based on surgeon requirements and clinical feedback
• Improve and modify existing tools to enhance performance, usability, and manufacturability
• Plan, write, and execute development, verification, and validation protocols and reports
• Maintain thorough design documentation, including DHF deliverables, throughout all development stages
• Support ongoing manufacturing by investigating nonconformities, participating in MRBs, and implementing ECOs
• Collaborate with internal teams and subcontractors on manufacturing process improvements
• Gain and maintain in-depth knowledge of Premia Spine systems and surgical techniques
• Provide surgical support as required to ensure proper instrument use and performance