$111,149 - $138,936 (Compensation could be higher based on education, experience and skill sets) Job Description Support the design and manufacture of medical devices, including creating 3-D designs using software such as SolidWorks, generating detailed 2-D drawings, writing engineering requirements, developing test methods, designing test fixtures, supporting product manufacturing, and solving issues through design, development, design transfer, launch, and post-market phases. Work closely with R&D, Operations, Quality, and Regulatory teams to support new product development and manufacturing process transfer, ensuring smooth transition to Manufacturing Engineering and Production for launch, and ongoing product support. Job duties: Work in cross-functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings. Translate abstract ideas into design solutions using methods such as sketches, 3D models, mock-ups, and prototypes. Communicate technical concepts effectively to non-technical team members. Develop test plans, protocols, and reports for design verification and validation. Create robust and manufacturable designs. Evaluate design solutions and components to determine optimal options. Develop and test prototypes during product development. Manage revision-controlled designs and documentation within the document control system. Support the transfer of designs from R&D to Manufacturing for volume production. Train technicians in assembly and testing of mechanical systems. Develop and maintain vendor relationships. Assist in solving technical challenges during manufacturing. Support post-market activities such as complaint investigations and product training. Ensure compliance with applicable laws, regulations, Quality Management System processes, and demonstrate ethics and integrity. Perform additional duties as assigned. Qualifications: Bachelor’s degree in Engineering or Scientific field. Minimum six (6) years of relevant experience in the medical device industry. Strong communication skills. Knowledge of mechanical engineering principles including Fluid Mechanics, Strength of Materials, Statics, and Dynamics. Expertise in SolidWorks, capable of creating complex designs, detailed 2D drawings, and BOMs. Proficient with MS Word, Excel, Outlook, and Teams. Advanced degree in Engineering or Scientific field (preferred). Experience designing components for injection molding. Experience in user-centric industrial design for medical devices. Experience with Finite Element Modeling. Design experience for enclosures, chassis, and spatial packaging. Knowledge of medical device regulations and FDA requirements. Experience with CAPA systems and complaint handling. Ability to receive inoculations for operating room environments.

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