Job Description

Principal Electrical Engineer
Contract M-F 40 hours weekly 3+ months

The Principal 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: 

·         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.

·         Work closely with Program Manager(s) to execute projects of varying scope

·         Design and development of test methods, fixturing, or instrumentation is often required

·         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

·         Extensive use of both Microsoft Excel and Word is required

·         Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations

·         Work with outside electrical engineering contractors to achieve development timelines 

Requirements: 

·         Bachelor’s Degree in electrical engineering or applicable scientific degree

·         7+ years of experience with medical product development 

·         C, Python or MATLAB fluency

·         PC Cad fluency

·         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

·         Microprocess, sensor, analog and power supply experience preferred 

·         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)  

Application Instructions

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