Imperative Care · 3 months ago
Sr R&D Engineer, Advanced Development
Imperative Care is focused on elevating care for patients suffering from stroke and other vascular diseases. The Senior R&D Engineer will design, develop, and launch innovative endovascular/neurovascular products, ensuring compliance with regulatory requirements and facilitating manufacturability.
Health CareMedicalMedical Device
Responsibilities
Serve as technical team member or lead on early-stage projects through project transfer to larger cross-functional teams and into formal design control programs, executing projects based on value improvement, line extensions, and compliance on commercialized products
Respond to technical field inquiries and perform root-cause investigations on product failures
Create, modify, and qualify test methods per FDA and regulatory requirements
Establish and/or tune detailed requirements including product specifications and appropriate test methods through activities such as competitive testing, literature review and KOL engagement
Create and execute product test plans for verification and validation of specifications using novel bench testing, model/fixture development, test method validation and ex/in vivo testing (as required)
Develop complex prototypes and refine designs in response to feasibility testing data, pre-clinical evaluations, and customer inputs
Author robust component/assembly drawings, specification documents, test protocols and reports
Ensure technical activities are properly documented; participate in and contribute to technical discussion sessions to generate new intellectual property
Perform design control activities for new product development including performing comprehensive design evaluation, contributing to risk analyses (Hazards/Harms, FMEAs etc.) and ensuring documentation is in accordance with Quality System requirements
Ensure that new products, components, and assemblies are designed to facilitate manufacturability. May contribute to the process of transferring product from development to manufacturing including fixture/tooling development and Manufacturing Process Instruction review
Qualification
Required
Bachelor's degree in engineering, or related discipline and a minimum of 5 years of related experience in the medical device or related regulated industry; or equivalent combination of education and work experience
Demonstrated experience of full R&D product life cycle and product design from concept to regulatory marketing approval
Statistical analysis Software (Minitab or similar) and CAD (Solidworks, ProE, similar)
Demonstrated knowledge of and exposure to product testing and data collection
Strong skill detailing project plans effectively with ability to complete projects independently or as part of a team, using evaluation, judgement and interpretation to select course of action
Experience working under regulated quality systems such as GMPs, ISO 13485/9001, and the MDD
Familiar with Design Control procedures and requirements
Excellent written and verbal communication skills required
Must be able to travel domestically and internationally
Preferred
MS in Engineering and experience in endovascular/neurovascular techniques and devices, with knowledge of relevant standards preferred
Benefits
Stock options
Competitive salaries
A 401k plan
Health benefits
Generous PTO
A parental leave program
Emotional health resources
Company
Imperative Care
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 StageTotal Funding
$558.97MKey Investors
Ally Bridge GroupD1 Capital Partners
2024-07-25Series E· $150M
2021-07-15Series D· $260M
2021-01-01Debt Financing· $40M
Recent News
BioWorld Financial Watch
2025-09-24
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