Senior or Principal R&D Engineer – stent/implant design – 2 spots open!
Lake Forest, CA
Primary responsibilities include:
- Design/improve stents and delivery system components and accessories.
- Apply Mechanical Engineering knowledge to the design and development of new products.
- Solve Mechanical Engineering problems at the component, subassembly, and system level.
- Support manufacturing process development.
- Implement design for manufacturability (DFM) improvements.
- Develop test methods for both feasibility/research & for Design Verification.
- Conduct testing on devices (both feasibility & Design Verification).
- Identify root cause and develop solutions to issues identified during testing.
- Create, update, and release quality system documents.
- Present/communicate findings to influence team/design/management.
- Work with vendors to improve vendor-supplied components and address issues as they arise.
- Design fixtures for both manufacturing and device/component testing.
- Support commercialization activities and manufacturing site transfers.
- Conduct all work in compliance with internal and external policies and procedures, QSR and FDA regulations and ISO standards.
- Bachelor’s degree in Engineering is required, 5 years experience minimum
- Exposure to design of experiments
- Design control systems
- Specification development
- Experience in the medical device industry with emphasis on minimally invasive procedures
- Proven Track record of early technical development and early-stage R&D all the way to commercialization.
- Ability to interact with cross functional partners and the ability to escalate issues.
- Advanced degree in Engineering is preferred.
- Knowledge and experience with implant and delivery system product development from design to product launch, catheters a plus.
- Will need to be a highly motivated self-starter who is able to achieve results with minimal direction.
- Knowledge of device Design Control, Quality Systems, documentation.
- Good communication skills, written and verbal.
- Experience working in cross functional teams and independent contributor role.
- Experience developing test plans.
- Experience with CAD and/or solid modeling in programs such as Solidworks.
- Experience with extrusions, materials, braided shafts, articulating designs, varied French sizes, etc.