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Principal Systems Engineer
2 months ago
About the Role
The Systems Engineer will play a critical role in translating customer needs into system requirements, defining system architecture, and completing systems analysis. This individual will work closely with cross-functional teams to develop instrument and module designs, test and refine them, and ensure they meet regulatory requirements.
Key Responsibilities
- Lead the development of system-level concepts and analysis for new project proposals, reviewing and critiquing concepts created by the proposal team.
- Prepare Systems Engineering cost and schedule estimates for major design development efforts, providing technical presentation support and consultation to the Business Development Team.
- Plan and lead engineering testing to evaluate operating characteristics of products or processes, translating test data into design requirements and criteria.
- Work with various engineering disciplines to develop instrument or module designs that meet system/module requirements.
- Lead Technical Design Reviews at various stages of development to ensure the conceptual/detailed approach and supporting analysis lead to a design that meets requirements.
- Contribute to System Integration and lead Design Verification by defining, specifying, and supervising testing, analysis, and integration activities, ensuring reports are prepared to document results.
- Support the design review and phase gate process to ensure engineering deliverables meet FDA/ISO requirements and standards.
- Oversee the development of requirements for different disciplines, such as Software, Electrical, Mechanical, Electro-optics, and others.
Requirements
- Bachelor's Degree in Engineering.
- 9 years of complex electro-mechanical instrument systems engineering experience.
- Hardware/software integration experience.
- Availability for daily onsite presence.
Preferred Requirements
- Master's degree in Engineering.
- Medical Device experience.
- Extensive development experience in software, mechanical, electrical, optics, fluidics, and other engineering disciplines, with knowledge of advanced theories, concepts, principles, and processes.
- Ability to provide technical leadership during the investigation of complex medical instrumentation products, overseeing the development of requirements for different disciplines.
