Staff Engineer, R&D
Position Overview
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 and designing test fixtures, supporting product manufacturing and problem 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 sustaining. 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 (i.e. complaint investigations, product training).
- Perform additional duties as assigned.
- Bachelor’s Degree in Mechanical Engineering.
- Eight (8) to ten (10) years of relevant product development experience.
- Ability to communicate effectively (both written and verbal) in English.
- Experience designing complex mechanical/electromechanical systems.
- Experience designing enclosures, chassis, and spatial packaging of components.
- 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.
- Advanced Degree in Mechanical Engineering.
- A minimum of six (6) years of medical device experience.
- Experience designing components optimized for injection molding.
- Experience with developing user centric industrial designs for medical devices.
- Experience with Finite Element Modeling.
- 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.