Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Sr. System Test 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
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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 .