Principal R&D Electrical Engineer

The Principal R&D Engineer will be located in Pittsburgh and is responsible for assisting and/or leading the development of medical devices. The primary responsibilities of this role include supporting all phases of device development, in particular the identification and evaluation of design options, the definition of product / performance specifications, and design verification and validation activities. Within a collaborative team environment, it will be expected that he or she will be a proactive communicator, collaborate well with others, manage their work efficiently, produce high quality work and consistently seek additional knowledge and skills. Creation of technical data, data analysis, and subsequent reporting will be an important aspect of this role.

In a typical day, you will:

• Provides technical leadership, and/or significant contributions, to product development projects and/or technology development efforts.
• Contributes to all aspects of product development activities and product design history files, including; requirements creation/documentation, ideation / prototyping, design / development, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions.
• Develops engineering solutions, investigates competing technologies
• Supports or leads efforts to evaluate and identify design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.
• Works directly with safety certification organizations to ensure compliance with applicable safety standards.
• Partners with the software developers to ensure electrical design works seamlessly within the software architecture, identifies potential issues, and negotiates trade-offs as required.
• Develops product verification and validation testing strategies, testing protocols and reports, and ensures products meet/exceed established specifications.
• Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
• Supports in ensuring product and performance specifications are appropriate and accurate.
• Supports marketing in the planning and creation of technical brochures, training programs, and technical presentations to customers and the sales force.
• Supports engineering leadership as required.

• Bachelor's, Master's or PhD degree in Electrical Engineering.
• Minimum of 10+ years of related experience
• Experience in Medical Device development.
• Working knowledge of, and experience in applying, FDA Design Controls and international standards.
• Working knowledge of printed circuit board design tools, such as Altium or OrCAD
• Knowledge of printed circuit board design and manufacturing processes. Must have expertise in development of schematics, selection of components and have up to date knowledge of developments in the electronics industry.
• Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
• Experience in the practical application of statistics and working knowledge of a statistical analysis package.