Senior System Engineer

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