Senior Process Engineer

We Are Hiring: Senior Process Engineer MESH Executive Solutions is recruiting a Senior Process Engineer for a global medical device company specializing in endovascular treatment and Class III devices, for its Israeli site in Herzliya (hybrid work available). Position Overview Develop, validate, and improve manufacturing processes for Class III medical devices and implants, working closely with R&D, Production, QA/QC, Regulatory Affairs, Supply Chain, and external suppliers. Key Responsibilities •  Develop and maintain manufacturing and assembly processes, defining parameters, operating ranges, acceptance criteria, and controls to improve robustness, repeatability, yield, cycle time, ergonomics, cost, capacity, and efficiency. •  Develop production equipment and design fixtures, jigs, tooling, and manufacturing aids using CAD, primarily SolidWorks; prepare detailed drawings and controlled documentation for implants, components, and tooling in accordance with applicable standards. •  Provide hands-on production support, investigate failures and nonconformities, and implement solutions to recurring issues. •  Support NPI, design transfer, manufacturing readiness, and production scale-up. •  Support supplier qualification and process transfer, improving external manufacturing robustness, capacity, scalability, quality, and delivery. •  Lead cross-functional engineering projects from planning through implementation. Qualifications •  Bachelor’s degree in Mechanical Engineering or Biomedical Engineering. •  At least 10 years of experience in process engineering, manufacturing engineering, mechanical design, or industrialization. •  At least 3 years of mechanical design and detailed technical drawing experience, including demonstrated fixture, jig, tooling, or production equipment design skills. •  Experience with Class III medical devices — required. •  Strong CAD proficiency, preferably SolidWorks, and ability to prepare accurate, controlled technical and manufacturing documentation. •  Hands-on experience developing, implementing, and validating manufacturing processes, supporting production, troubleshooting, performing root cause analysis, and implementing corrective actions. •  Ability to independently manage multiple projects and priorities; strong teamwork, communication, creativity, and initiative, with willingness to work directly with production personnel, equipment, tooling, and products. •  Excellent written and spoken English. •  Experience with implantable, catheter-based, or other complex medical devices; ISO 13485 quality systems; and familiarity with U.S. FDA and European requirements — advantages. •  Experience with NPI, design transfer, scale-up, external manufacturers, and international suppliers — advantages. •  Experience with cleanroom or controlled-environment manufacturing and processes such as manual assembly, suturing, bonding, welding, crimping, heat treatment, cleaning, or packaging — advantages.