We are currently hiring for a Senior or Principal Product Development Engineer with an Electrical background who has experience with design, development and certification medical electrical equipment. This individual will contribute as a technical leader for the design and development of electrical based systems and subsystems to support Abiomed’s Impella product line. The Product Development Engineer will be responsible for overseeing the development of system architecture, hardware design, detailed circuit design, software integration, verification plans, and documentation. Working knowledge of medical electrical equipment safety standards, and collateral standards, such as 60601-1 and EMC standards such as 60601-1-2 is required. The individual must independently plan and manage his/her own, and other team members’ work activities to achieve program objectives and deliver large scale projects both within Abiomed and in coordination with external strategic development partners.
Those activities include both technical and project activities with primary accountability and responsibility for project definition, deliverables of the design, and throughout the field release of the product. We are looking for a motivated self-starter who is energetic, has a ‘make it happen’ attitude and can thrive in a fast-paced, cutting edge environment.
Responsibilities
Work with product management to carryout VOC investigations. Collect, analyze, and document user need results; lead brainstorming efforts to identify potential solutions.
Provide electrical expertise and technical leadership on the project and execute on program management requirements and deliverables.
Ability to lead cross-functional technical teams to achieve project objectives.
Independent analysis of solutions for product performance and use problems, exhibiting creativity, foresight, innovation, and judgment in anticipating and solving these problems.
Lead design reviews that prevent design errors and ensure design and process development will meet requirements.
Establish and execute the technical development plan, process, and design strategy.
Manage technical and programmatic risk, ensuring effective risk identification, assessment, and mitigation; especially as it applies to electrical design, electrical safety, EMC and other patient risks.
Effectively communicate activity status, issues, and mitigation plans with key stakeholders.
Manage the successful hand-off the product to in-house or OEM manufacturing teams.
Ensure the technical integrity of the product design.
Efficiently address, identity the root cause, and resolve any field issues which may arise.
Work with Industrial Design and Human Factors experts to deliver best-in-class product designs.
Collaborate to ensure compliance with the company’s quality policy, as well as all applicable regulatory and notified body requirements
Skills/Requirements
Bachelors of Science degree in Electrical or Electronic engineering, MS degree preferred.
Senior Engineer typically requires 6-9 years’ experience in the design of complex medical electrical products or systems. Principal Engineer typically requires 10+ years’ experience.
Job Skills
Knowledge of medical electrical products and regulating standards.
Working knowledge of medical electrical equipment safety standards, and collateral standards, such as 60601-1 and EMC standards such as 60601-1-2, and how to design products to meet these standards.
Experience with safety testing, EMC testing and risk management file review at a NRTL leading to the listing of medical products.
Electromechanical design experience including electrical circuit design of analog, digital, and mixed signal systems.
Experience with the integration of custom circuitry to embedded PC systems and subcomponents.
Experience with, and understands, PCB layout, fabrication and assembly processes.
Experience with embedded software programming in C++
Experience interfacing with external firms and suppliers (design and contract manufacturers)
Able to lead the development of Fault Tree Analysis (FTA) and Failure Mode and Effects Analysis (FMEA)
Ability to conduct and drive empirical modeling and analytical testing activities.
Experience with electrical design software tools (Orcad schematic capture and PCB layout)
Demonstrated history of meeting the expectation and requirements of internal customers.
Demonstrated history of meeting or exceeding goals and getting results.
A history of sound judgment and decision-making in balancing cost, schedules and quality objectives.
Technical leadership and mentoring skills with a clear high performance orientation; demonstrates energy, enthusiasm, and creativity in problem solving.
Team oriented. Proven leadership and teamwork skills in a cross-functional engineering environment; ability to motivate and empower team members; set and manage expectations.
Demonstrated performance building and leveraging partnerships.
Possess a strong working knowledge of FDA's Quality System Regulation (QSR) and practical application through design control, SOP's, verification, and validation testing
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.
Please note that we do NOT accept unsolicited resumes or candidate referrals from recruiters and agencies that are not already on our preferred vendor list.
