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.

Required Qualifications:

• Bachelor’s degree in Engineering is required, 5 years experience minimum
  • Exposure to design of experiments
  • Design control systems
  • Specification development
  • Prototyping
• Experience in the medical device industry with emphasis on minimally invasive procedures

Preferred Qualifications:

• 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.