Mechanical Engineer

The Mechanical Engineer II – will be responsible for the design, development, and manufacturing of our robotic medical device components. This role will collaborate closely with cross-functional teams to ensure the successful translation of design concepts into robust and efficient manufacturing processes. Duties/Responsibilities • Develop fixtures, jigs, and tooling to support assembly, calibration, and functional testing for pilot builds and manufacturing scale-up. • Support production line setup and resolve mechanical issues during ramp-up and sustaining phases. • Support the development of V&V test protocol, report, test fixtures and equipment. • Participate in the design and development of mechanical components and assemblies from concept to production release. • Ensure compliance with Good Documentation Practices (GDP) throughout the entire product development process, including design reviews, protocols, reports, drawings, specifications and BOM. • Collaborate with quality engineers to address CAPAs, NCRs, and root cause investigations. • Incorporate clinical and marketing feedback into design outputs to align with customer needs and regulatory requirements. • Prepare the product for commercialization by ensuring successful transition from development to manufacturing including supporting regulatory submissions and product launch activities. • Hands-on fabrication, assembly, and troubleshooting of prototypes as part of product development process. • Participate in design reviews and contribute to continuous improvement initiatives for manufacturability and compliance. • Foster positive, collaborative relationships with vendors and suppliers to ensure timely project delivery. Required Skills/Abilities • Proficiency in CAD software and simulation tools. (Solidworks is preferred) • Extensive experience in designing electro-mechanical systems. • Expertise in FEA, GD&T and tolerance stack-up analysis. • Strong knowledge of DFM, especially for injection molding and machining. • Ability to conduct root cause analysis and implement solutions in a fast-paced environment. • Ability to conduct engineering studies, interpret results and incorporate them in design. • Ability to write and review V&V test protocols and reports. • Strong communication skills, both written and verbal, for effective collaboration with internal teams and vendors. • Hands-on experience in prototyping, assembly and troubleshooting