Staff R&D Engineer, Devices

Imperative Care•Campbell, CA

1d•$160,000 - $185,000•Onsite

About The Position

Imperative Care is seeking a Staff R&D Engineer, Devices to join their team in Campbell, California. This is an on-site, full-time role focused on developing breakthroughs in stroke and vascular disease treatment. The engineer will be responsible for leading technical innovation, design, development, manufacturability, and testing/verification/validation of new medical devices, from early stage through commercial release and transfer to manufacturing. The role requires a hands-on approach and collaboration with various teams and physician partners to define product requirements, create designs using CAD software, and conduct prototyping and preclinical testing.

Requirements

Bachelor’s or master’s degree in mechanical engineering, biomedical engineering, or related field.
8+ years (BS) or 6+ years (MS) of hands-on experience in the medical device industry.
Strong background in intravascular medical device design, development, prototyping, executing design verification and test method validations, and manufacturing methods and controls, with a focus on guidewires, stents, stent delivery devices, catheters, and/or similar devices.
Familiarity with special-purpose machine design, automation, precision machining (e.g., centerless grinding and CNC Swiss and laser micromachining), equipment and manufacturing methods used for device fabrication, as well as process development and validation within a regulated manufacturing environment to support activities both in-house and in collaboration with contract manufacturer(s).
Experience with advanced materials such as polymers, stainless steel, platinum, hydrophilic coatings, and nitinol, as well as related precision fabrication and processing/machining techniques (e.g., tube drawing, coil winding, braiding, laser processing, grinding, EDM, CNC).
Must be able to travel domestically and internationally, as necessary.

Responsibilities

Lead technical innovation, design, development, manufacturability, and testing/verification/validation of new medical devices, including specialty devices used in the interventional neurovascular and vascular markets from early stage through commercial release and transfer to manufacturing according to established Design Control procedures.
Work closely with Marketing, Clinical Engineering, and physician partners to define product requirements, create designs using CAD software (Solidworks), and lead prototyping and bench and other preclinical testing and experiments to ensure product performance, reliability, and safety.
Collaborate cross-functionally with Process Development, Quality, Regulatory, Marketing, and Mfg/Ops teams within Imperative Care and contract manufacturer(s) to ensure new product manufacturability (DFM) and robust process control and alignment with design specifications, quality systems, operational capabilities, and cost targets.
Optimize and scale existing processes to improve efficiency, yield, and product quality, working with outside partners as needed.
Support and work collaboratively with contract manufacturing partners for the design, implementation, and validation of the related manufacturing equipment and processes needed for scalable, high-accuracy medical device production.