Staff R&D Engineer - Devices jobs in United States
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Imperative Care · 21 hours ago

Staff R&D Engineer - Devices

Imperative Care is focused on elevating care for patients suffering from stroke and other vascular diseases through innovative medical technologies. They are seeking a hands-on R&D Engineer to lead the design, development, and testing of new medical devices, ensuring compliance with medical device regulations and collaborating with various functional groups.

Health CareMedicalMedical Device
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H1B Sponsor Likelynote

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)

Qualification

Medical device design3D CAD skillsDesign Control systemInjection molded partsRegulatory complianceProject managementCross-functional collaboration

Required

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

Benefits

Stock options
Bonus
Competitive salaries
A 401k plan
Health benefits
Generous PTO
Parental leave program
Emotional health resources

Company

Imperative Care

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Imperative Care is singularly dedicated to finding meaningful answers to unsolved problems in stroke.

H1B Sponsorship

Imperative Care has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (3)
2023 (5)
2021 (1)

Funding

Current Stage
Late Stage
Total Funding
$558.97M
Key Investors
Ally Bridge GroupD1 Capital Partners
2024-07-25Series E· $150M
2021-07-15Series D· $260M
2021-01-01Debt Financing· $40M

Leadership Team

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Lara Abbaschian
Senior Director, R&D
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Company data provided by crunchbase