The Senior Electrical Engineer will be conducting and document detailed root-cause failure investigations and addressing corrective actions. Responsible for system architecture design, hardware design, detailed circuit design, verification plans and documentation of a variety of medical devices.
Principle Duties and Responsibilities:
Responsible for investigating, resolving and documenting internal and external complaints for released clinical product.
Analyze console data to confirm symptom and identify failure mode.
Troubleshoot failures to system, subassembly and component level.
Document the investigation work; provide conclusions and recommendations for corrective actions.
Address corrective actions for failures.
Lead, or be part of a team, in the development of electronic medical devices including system architecture and detailed circuit design/implementation.
Work with and coordinate product development activities with mechanical, software, and manufacturing engineering as required.
Provide status updates to Program Managers as required
Identify and effectively manage critical issues.
Define strategy for design and manufacturing efforts
Skills/Requirements
BS in electrical/electronics engineering required.
8 years of related work experience desired.
Detailed and methodical approach to failure investigations.
Hands-on electrical circuit test and troubleshooting experience of analog, digital, and mixed signal systems.
Experience in systems design, allocation of requirements, and analyses (system, subsystem, and component modeling)
Integration of custom circuitry to embedded PC systems and subcomponents
Experience interfacing with external firms and suppliers (design and contract manufacturers)
Fluent with electrical design software tools (Orcad schematic capture and PCB layout)
Possess a strong working knowledge of FDA's Quality System Regulation (QSR) and practical application through design control, SOP's, verification, and validation testing
Familiarity with medical device standards and CE mark requirements for international use a plus
Knowledge of medical device agency approval requirements desired (EMI, EMC, etc.).
Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written)
Ability to exercise judgment methods, techniques and evaluation criteria for obtaining results.
Execute tasks in a timely manner without direct supervision.
Project lead experience a plus
Must be proficient in Microsoft Office Suite. Working knowledge of SAP desired.
ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.
