Mechanical Engineer
Our client is a technology-driven company focused on the development of advanced robotic solutions within the medical device sector, delivering high-precision systems designed to operate in highly regulated clinical environments. The organization combines engineering excellence with deep healthcare expertise, ensuring that all products meet the highest standards of safety, reliability, and performance required in surgical applications.
Operating at the intersection of robotics, engineering, and medicine, the company works under strict regulatory frameworks, integrating quality, risk management, and validation processes throughout the entire product lifecycle. The environment is highly multidisciplinary, offering engineers the opportunity to contribute to innovative solutions that have a direct and tangible impact on patient outcomes and clinical practices.
Mission
The Mechanical Engineer will be responsible for the design, development, and validation of mechanical components and subsystems for advanced robotic platforms in the medical device environment. The role is critical in ensuring that designs comply with stringent regulatory standards, while achieving the highest levels of precision, reliability, and manufacturability required for surgical applications.
Responsibilities
Mechanical Design and Development
- Design and develop high-precision mechanical components and assemblies for robotic medical systems.
- Create detailed 3D models, engineering drawings, and technical specifications aligned with product and regulatory requirements.
- Perform tolerance analysis and ensure robustness and reliability of mechanical designs.
Medical Device Product Development and Validation
- Participate in the full product lifecycle within a regulated medical device environment, from concept to industrialization.
- Define and execute verification and validation plans בהתאם to medical device standards.
- Ensure traceability of design inputs/outputs and compliance with design control processes.
Regulatory Compliance and Quality
- Ensure all mechanical designs comply with applicable medical device regulations and standards (e.g., ISO 13485, MDR).
- Collaborate with Quality and Regulatory teams in risk analysis (FMEA) and documentation processes.
- Support audits, certifications, and regulatory submissions with accurate technical documentation.
Cross-functional Collaboration
- Work closely with electronics, software, and clinical teams to ensure system-level integration.
- Participate in design reviews and technical decision-making processes.
- Align mechanical solutions with clinical usability and safety requirements.
Manufacturing and Industrialization Support
- Ensure design for manufacturability and assembly (DFMA) in a regulated production environment.
- Collaborate with suppliers and manufacturing partners to validate components and processes.
- Support the transition from prototype to serial production under quality-controlled conditions.
Required Qualifications
- Degree in Mechanical Engineering or a related discipline.
- Minimum of 3 years of experience in mechanical design within regulated environments.
- Experience in medical devices, robotics, or high-precision engineering industries.
- Strong proficiency in CAD tools (e.g., SolidWorks, CATIA or similar).
- Understanding of medical device regulations and design control processes.
- Professional proficiency in English.
- Strong analytical skills and attention to detail.
Preferred Experience
- Hands-on experience working under ISO 13485 or similar quality management systems.
- Experience with validation, testing, and laboratory environments in medical devices.
- Familiarity with risk management methodologies such as FMEA.
- Knowledge of manufacturing processes such as machining, injection molding, or additive manufacturing.