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