Mechanical Engineer

A high-innovation Medical Device startup developing the world’s most compact and powerful cardiac pump technology. Positioned at the forefront of cardiovascular engineering, the company’s life-saving mission is backed by advanced R&D and sophisticated manufacturing processes.

Operating from a state-of-the-art facility in the Sharon region, the organization fosters an elite engineering culture where mechanical, biomedical, and materials sciences converge.

This is a pivotal time to join a growing team as they transition high-complexity prototypes into globally regulated medical products.

The Role & Responsibilities

• NPI Leadership: Spearheading the New Product Introduction (NPI) process, ensuring a seamless handover from research and development to the production floor.
• Manufacturing Optimization: Designing and developing specialized production equipment, custom jigs, and fixtures to enhance manufacturing efficiency and precision.
• Validation & Compliance: Leading formal equipment and process validations, including the creation and execution of IQ, OQ, and PQ protocols.
• Operational Support: Providing high-level technical support to the production line through expert troubleshooting and rigorous Root Cause Analysis (RCA).
• Design Iteration (ECO): Managing and implementing Engineering Change Orders (ECO) to continuously improve product design and manufacturing workflows.
• Documentation Excellence: Authoring comprehensive production documents, test protocols, and detailed engineering reports in accordance with medical regulatory standards.
• Supply Chain Collaboration: Working closely with external vendors and subcontractors to ensure component quality, process efficiency, and regulatory alignment.

Requirements-

• Academic Excellence: B.Sc. in Mechanical, Biomedical, or Materials Engineering with a strong mechanical orientation – Mandatory.
• Professional Depth: 3–5 years of hands-on experience in NPI or manufacturing engineering roles – Mandatory.
• CAD Mastery: Expert-level proficiency in SolidWorks, including experience with PDM systems – Mandatory.
• Process Development: Proven track record in developing and optimizing manufacturing processes from concept to production – Mandatory.
• Quality & Regulatory Literacy: Strong familiarity with Quality Assurance (QA) and medical regulatory standards (e.g., ISO 13485).
• Med-Tech Context: Prior experience within the Medical Device industry – Significant Advantage.
• Analytical Capabilities: Excellent problem-solving skills with a focus on data-driven decision-making.
• Interpersonal Skills: Ability to work effectively within multidisciplinary teams and communicate technical concepts clearly, both verbally and in writing.