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Our smaller medical device client is adding a Sr or Principal Systems Engineer to the team! The engineer will provide interdisciplinary research and product development leadership from inception through pilot production through commercial launch. He or she must be able to work effectively with all functional groups to define system-level requirements and resolve cross-functional issues. Success in this position relies heavily on meeting dates and maintaining accountability while using experience and judgement to develop products and meet goals with minimal supervision. This engineer will be a key role in the R&D organization and needs to be both a strong individual contributor responsible for critical project work-streams, but also someone who can collaborate effectively with a team of highly skilled engineers and technicians to develop, test, and document products in compliance with the needs of the medical device quality system.
Your role with the company:
- Develops new products and processes from initial design to market release
- Translates customer needs into product requirements and design specifications
- Interfaces with Physicians & Medical personnel to obtain feedback on concepts and performance of new devices
- Analyzes design trade-offs necessary to meet the objectives of disparate functional groups such as marketing, clinical, regulatory, quality, R&D (electrical, mechanical, and software) and manufacturing operations.
- Designs and coordinates complex engineering tests and experiments; summarizes, analyzes, and draws conclusions from test results; and generates reports and/or presentations to communicate and contextualize results
- Possesses extremely strong documentation skills throughout all phases of design control from research and development to manufacturing; able to synthesize complex information in a clear and concise manner for both technical and non-technical audiences
- Manages relationships with external vendors and collaboration partners to ensure the quality and timeliness of deliverables enables project success
- Project manages cross-functional teams, including task planning, system requirement definition, vendor selection, design & development, risk management, verification and validation, and transfer to manufacturing
Desired profile:
- Bachelor’s degree or higher in Electrical Engineering, Biomedical Engineering, or Mechanical Engineering
- 5-8+ years of product development experience in a medical device company, ideally start-up experience
- 5+ years of progressively responsible system-level medical device design, development, and validation experience throughout the entire product development cycle
- Proven track record in delivering key documents such as requirements, usability protocols, risk management assessments, verification and validation strategies, and compliance testing reports.
- Strong background in developing complex electromechanical systems that encompass both capital and disposable components
- Well-rounded professional capable of proficiently designing complex systems involving hardware, electrical, and software elements, all while maintaining a strong commitment to product safety, security, and quality
- Demonstrated experience in the development of testing procedures and equipment for verification and validation testing, and transfer into manufacturing and development of appropriate process manufacturing controls and documentation
- Experience with designing, developing, and commercializing a medical device product incorporating a custom ultrasound system
- Experience with CAD software, preferably SolidWorks
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