Senior Quality Engineer, Imperative Care
$120-130k
Plus stock options
Office located in Campbell, CA
Stroke intervention & treatment technology
Be an early applicant
Stroke intervention & treatment technology
201-500 employees
Be an early applicant
$120-130k
Plus stock options
Office located in Campbell, CA
201-500 employees
Company mission
Imperative Care is addressing gaps across the entire patient journey — from detection through recovery — to elevate care for patients suffering from stroke and other devastating vascular diseases.
Role
Who you are
- Do you want to make a real impact on patients?
- Bachelor’s degree in engineering, or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and work experience
- Advanced degree and experience with catheters, endovascular/neurological devices is highly desired
- Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)
- Demonstrated knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices
- Excellent communications skills (both written and verbal)
- Proven ability to provide thorough and meticulous review of documents
- Proven ability to write clear, concise, and well thought out technical documentation with focus on failure investigations and inspection procedures
- Strong ability to perform multiple tasks concurrently with accuracy
- Proficiency with Microsoft Office products
What the job involves
- Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care
- Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do
- As a senior professional in this field, this position will use solid knowledge and experience and contribute to the development, manufacture, and distribution of Imperative Care’s medical device products by applying Quality Engineering principles to all applicable processes and procedures in accordance with the Company’s Quality Policy and Quality Objectives
- Provide quality input to define required validations necessary to support significant process changes on commercially launched products
- Collaborate with team members to define validation requirements, specifications, testing, and component/product acceptance activities
- Analyse data by completing hypothesis, normal distribution, and process capability analysis tests intended to provide input on the quality of the product/process being evaluated/monitored
- Create and revise quality assurance procedures, as required, to maintain compliance to changing regulations and guidance documents
- Train broad audience on the use of procedures to comply with Quality Systems and Regulations
- Serve as liaison with laboratories conducting routine product testing or root cause analysis related to testing failures or deviations
- Conduct methodical root cause investigations and provide guidance to prevent recurrence
- Work with suppliers to qualify and maintain approved supplier status. May evaluate supplier notification of change and recommend necessary actions to maintain compliance
- Perform statistical analysis of manufacturing data and quality processes and creation of reports based on quality documentation
- Review DCO’s involving product or process changes to ensure consistency with company procedures and quality system compliance
- Conduct and review Risk Management assessments on product and process changes
- Conduct failure mode effect analysis on product
- Support projects (including product enhancements) in an aggressive manner consistent with corporate objectives
- May provide quality metric data to various functional groups within the organization
Our take
Strokes pose a real and present threat to millions of people around the world, but many needs in stroke care are still not being met. Imperative Care is setting out to change this by developing innovative solutions for preventing and treating strokes.
Imperative Care was founded by an expert neuroendovascular surgeon and a serial entrepreneur, and its forward-facing technology and ambitious growth are testament to this partnership. Imperative has maintained a strong focus on physician-led care, developing its technology in close collaboration with working doctors. This has helped the company to identify and address key pain points in the existing stroke care system.
Imperative Care has scaled relatively quickly since it first launched, and this is a result of its rapid innovation cycle and its considerable funding success. Investment awarded to Imperative in 2024 will fuel its growth and product development in the coming years.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
21% employee growth in 12 months
Company
Funding (last 2 of 4 rounds)
Jul 2024
$150m
SERIES E
Jul 2021
$260m
SERIES D
Total funding: $498m
Company benefits
- Stock options
- 401k
- Health benefits
- Team events, competitions & activities
Company HQ
Campbell, CA
Leadership
Fred Khosravi
(CEO)Was Senior Product Development Engineer at Alcon, and Product Development Manager at Focal Therapeutics. Is currently Director of Instylla Medical.
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