Principal Electrical Engineer - high voltage plasma systems design, medical device
Location
Waltham, MA | United States
Job description
InnoTECH Staffing is looking to hire a Principal R&D Electrical Engineer who has experience leading the design of high-voltage plasma generation systems for a medical device company in Waltham, MA.
The Principal Research and Development Electrical Engineer has the responsibility and authority for the development and commercialization of new products and improvement of respiratory products. Provides technical leadership for teams developing and launching respiratory medical devices by directing and supervising design, development, verification, and validation activities.
Responsibilities: - Lead the design in high-voltage plasma generation systems
- Independently lead development projects as assigned with the goal of launching new products or improving existing ones. May be asked to assume the role of technical lead, driving all aspects of design as it relates to respiratory products and instrumentation.
- Lead the design and development of complex analog and digital circuits, including sensors, power supplies, signal acquisition/conditioning, control, batteries, ESD protection, EMI reduction and micro-controllers
- Utilize circuit simulation and modeling techniques to support design and development
- Lay out and construct a variety of prototype tools, boards and test fixtures required for development purposes
- Conduct characterization testing, verification and analyses related to feasibility and function
- Prepare requirements documents, design verification and validation documents, FMEA documents, as well as conducting technical design reviews for hardware, firmware and PCBs
- Troubleshoot and debug intermittent system level problems down to root causes with respect to circuit design, firmware, PCB and component failures with latest electrical and electronic equipment
- Work closely with Program Manager(s) to execute projects of varying scope
- Design and development of test methods, fixturing, or instrumentation is often required
- Play a lead role in system and sub-system design and collaborate with engineering teams to achieve project goals.
- A strong working knowledge of medical device design, and able to apply principles in product development excellence
- Apply in-depth understanding of FDA Design Controls to development programs. All activities must be performed in compliance with the Quality System.
- Ensure a detailed and well-tested product design that meets user needs, regulatory and legal requirements
- Define, clarify and document product and component requirements
- Assist in the design and development of verification and validation testing
- Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
Requirements: - Bachelors Degree in electrical engineering or applicable scientific degree, Masters preferred.
- 10+ years of experience with medical product development
- Proficient in schematic capture and circuit board layout using Altium
- Experience with high-voltage transformers, power supplies and electronic systems design
- C, Python or MATLAB fluency
- Extensive use of both Microsoft Excel and Word is required
- Experience with ISO requirements, GMP guidelines, FDA regulations, GDPs, International regulation, and medical device design control preferred
- Possess deep knowledge of structured development and engineering processes and methodologies
- Able to work within a cross-functional organization
- Exhibits strong self-management, prioritizing and multi-tasking skills to work within deadlines
- A team player by nature with the ability to work independently with a result-oriented can-do attitude
- Proven success in requirements management and traceability
- Possess or able to develop a strong knowledge of international standards applicable to medical devices, including ISO13485, ISO14971, and IEC60601 and its collateral standards
- Expertise in common risk management techniques (FMEA, FTA, ETA)
Compensation includes base salary in the $160K to $190K area, PLUS bonus, equity and full benefits.
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