Job Information
J&J Family of Companies Senior System Engineer in Danvers, United States
Senior System Engineer - 2406166954W
Description
Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Sr. System Engineer located in Danvers, MA.
The Sr. System Test Engineer will work with hardware engineers to testing advanced hemodynamic support medical device, Automated Impella Controller. The candidate will read and understand design and development requirements to create comprehensive verification test plan and protocols.
Understand device design and core technologies in order to inform test method development
Review, update, understand and determining the scope of testing required
Develop test methodologies within framework of SOP’s and FDA guidelines
Create verification and validation test plans
Write concise and effective test protocols
Informal and formal test execution of verification and validation protocols
Produce test reports, document test results, maintain records and assure traceability
Creating and evaluating test fixtures needed for product design verification
Contributing to design failure investigations that may impact Risk Assessment, Hazard Analysis, and FTA’s
Qualifications
QUALIFICATIONS:
BS or MS in Electrical Engineering, Mechanical, Software Engineering, Biomedical Engineering or related field required
Minimum of 5 years of Verification & Validation experience
Medical Device Experience
understanding of 60601-1 standards
Prior experience in embedded device testing (preferred)
Fundamental understanding of design controls
Familiarity with JAMA requirements management software
May require up to 5% travel – US & EU
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location NA-US-4887-Danvers
Organization ABIOMED Inc.(6942)
Job Function QA/Test Engineering
Req ID: 2406166954W
J&J Family of Companies
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