Staff Engineer, R&D
1 month ago
Support the design and manufacture of medical devices, including creating 3-D designs using a design 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 counterparts, Operations, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch and continue supporting product sustainment. Job duties:
- Work in cross-functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings to meet these needs.
- Ability to translate abstract ideas into design solutions using variety of methods including but not limited to simple hand sketches, 3D models, mock-ups, and prototypes.
- Communicate technical concepts effectively to non-technical team members to facilitate cross-functional understanding.
- Develop test plans, protocols, and reports as part of design verification and validation.
- Develop designs that are robust and optimized for manufacturability.
- Evaluate different design solutions and components to determine optimum solution for the application.
- Develop and test protypes as required during the course of product development.
- Release revision-controlled designs and documentation in document control system.
- Support the design transfer of product from R&D to Manufacturing for volume production.
- Train Technicians to assemble and test mechanical systems.
- Develop and maintain vendor relationships.
- Assist with solving technical challenges encountered during manufacturing.
- Support post market sustaining efforts (e.g., complaint investigations, product training).
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
Qualifications
- Bachelor's degree in Engineering or Scientific field.
- Minimum six (6) years of relevant work experience in medical device industry.
- Strong written and verbal communication skills.
- Working knowledge of fundamental mechanical engineering principles including Fluid Mechanics, Strength of Materials, Statics, and Dynamics.
- Strong design expertise using SolidWorks including ability to generate complex designs with clean and organized design history, detailed 2D drawings and BOMs.
- Strong design expertise developing and validating embedded software/firmware for medical devices following applicable requirements (e.g., ISO 62304).
- Strong design experience in designing and developing electro-mechanical medical device and associated test requirements (e.g., IEC 60601 standards series).
- Proficient computer skills, including MS Word, Excel, Outlook, and Teams.
- Advanced degree in Engineering or Scientific field.
- Experience designing components optimized for injection molding.
- Experience with developing user centric industrial designs for medical devices.
- Experience with Finite Element Modeling.
- Experience designing complex mechanical/electromechanical systems.
- Experience designing enclosures, chassis, and spatial packaging of components.
- Experience designing active implantable devices and knowledge of associated requirements (e.g., ISO 14708).
- Experience developing and testing mobile applications for medical devices.
- Working knowledge of medical devices and FDA regulations.
- Experience with CAPA systems, including complaint handling.
- Ability to receive the appropriate inoculations required to enter an operating room environment.
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