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
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