Staff R&D Engineer - Devices

Imperative Care•Campbell, CA

1d•Onsite

About The Position

This role is for a hands-on, individual contributor R&D Engineer to 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. The ideal candidate will have a strong background in intravascular medical device design, development, and manufacturing methods and controls, with a focus on guidewires, stents, stent delivery devices, catheters, and/or similar devices. Ideal candidates will also have familiarity with equipment and manufacturing methods used for device fabrication, as well as process development and validation within a regulated manufacturing environment, both in-house and in collaboration with contract manufacturer(s). Primary focus will include defining product requirements, creating designs using CAD software, prototyping, and leading bench and other preclinical testing and experiments to ensure product performance, reliability, and safety. Candidate must also manage project timelines, conduct risk management, interact with marketing and physicians for user input, and ensure all design and testing activities comply with medical device regulations such as FDA Quality System Regulations and ISO 13485. This role also involves close cross-collaboration with other functional groups including Quality, Regulatory, Marketing, Process Development, and Mfg/Ops.

Requirements

Bachelor’s degree in mechanical engineering, biomedical engineering, or related field, and 8+ years of medical device or combination product industry experience, including development, designing and prototyping, and executing design verification and test method validations; or Master’s degree and 6+ years of experience
Familiarity and experience driving product designs from concept to commercial release under a Design Control system
Experience designing injection molded parts for medical devices
Strong 3D CAD skills (SolidWorks or similar), with an ability to interpret GD&T and tolerance stack-ups and to generate engineering drawings
Experience working in compliance with quality systems designed to meet regulatory requirements such as FDA QSR, ISO 13485, MDR, GMP, and knowledge of relevant medical device standards and guidance documents

Responsibilities

Serve as technical team member and/or lead projects from early stage through commercial release and transfer to manufacturing according to established Design Control procedures.
Design, develop, and test device components (e.g., shafts, distal tips, coatings, steering mechanisms) and assemblies using advanced materials such as polymers, stainless steel, hydrophilic coatings, platinum, and nitinol and precision fabrication and measuring tools (as applicable).
Lead prototype fabrication utilizing in-house lab and/or contract manufacturer components, processes, and equipment such as polymer extrusions, lamination, shaft braiding and coiling, injection molding, and adhesive bonding.
Lead risk analysis activities and develop product testing plans and protocols; set up and run or lead product testing and protocols in accordance with project plans.
Generate and maintain detailed documentation, including Design History Files (DHFs), FMEAs (Failure Modes and Effects Analysis), and hazard analyses. Ensure all work complies with relevant medical device regulations and standards (e.g., ISO 13485, ISO 11070, FDA 21CFR820).