The Senior Electrical Engineer will be responsible for system architecture design, hardware design, detailed circuit design, software integration, verification plans, and documentation of a variety of medical devices.
Primary Duties and Responsibilities:
Lead, or be part of a team, in the development of electronic medical devices including system architecture and detailed circuit design/implementation.
Assist in setting design goals and specifications for product development efforts.
Work with and coordinate product development activities with mechanical, software, and manufacturing engineering as required
Responsible for investigating and resolving internal and external complaints for released clinical product
Assist department heads and program managers in resource planning for upcoming projects/phases
Provide status updates to Program Managers as required
Identify and effectively manage critical issues
Define strategy for design and manufacturing efforts
Perform and document detailed failure analysis for clinical product
Skills/Requirements
Job Qualifications:
BS in electrical/electronics engineering required, MS desired
8 years of related work experience desired. Previous Medical device product development experience required.
Project lead experience a plus
Electromechanical design experience
Thorough knowledge of digital and analog electronics required.
Hands-on electrical circuit design 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
Detailed, methodical approach to failure investigations
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.
Able to prioritize tasks.
Must be proficient in Microsoft Office Suite. Working knowledge of SAP desired.
ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Veteran/Disabled.
