Staff R&D Engineer - Devices
Campbell, CA
Full Time
R&D Devices
Experienced
Title: Staff R&D Engineer - Devices
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.
What You’ll 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).
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.
- 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).
- 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
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.
Join Us! Imperative Care
Salary Range: $153,000 – 176,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, bonus, health benefits, generous PTO, a parental leave program and emotional health resources.
The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.
Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.
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