Staff R&D Engineer, Guidewire

Imperative Care • Campbell, CA

20h • $161,000 - $185,000 • Onsite

About The Position

This position is based in our Campbell, California offices. This position is on-site, full-time. Why Imperative Care? Do you want to make a real impact on patients? As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do. 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).

Requirements

• Bachelor’s or master’s degree in mechanical engineering, biomedical engineering, or related field with 8+ years (BS) or 6+ years (MS) of hands-on experience in medical device industry experience, including development, designing and prototyping, and executing design verification and test method validations; or equivalent combination of education and work experience
• Familiarity and experience driving product designs from concept to commercial release under a Design Control system
• Strong 3D CAD skills (SolidWorks or similar), with an ability to interpret GD&T and tolerance stack-ups and to generate engineering drawings
• Experience with precision processing/machining techniques (tube drawing, coil winding, braiding, laser processing, grinding, EDM, CNC) for challenging materials like stainless steel, platinum, and nitinol (wire and tubing forms)
• Must be able to travel domestically and internationally, as necessary; up to 25%

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 centerless grinders, laser cutters/welders, polymer extrusions, lamination, shaft braiding machines, and coil winders and coiling, injection molding, and adhesive bonding
• Proactively troubleshoot, perform root cause analysis (RCA), implement corrective and preventive actions (CAPA), and optimize existing production processes for improved efficiency, yield, and quality
• 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 and to optimize and scale existing processes to improve efficiency, yield, and product quality

Benefits

• Employee Benefits include a stake in our collective success with stock options, bonus, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level