Senior Staff Systems Engineer (HYBRID)
About The Position
Lead end-to-end design, development, and evaluation of complex medical device systems. Apply advanced engineering principles and mentor team members on best practices. Translate user needs into system requirements and scalable architectures. Define, decompose, and allocate requirements across multi-disciplinary teams (EE, ME, SW). Lead concept phase activities and drive resolution of complex design issues. Conduct and lead analytical studies (trade-offs, optimization, performance, risk assessments). Oversee system integration, verification, and validation activities. Drive product risk management, including failure analysis, safety requirements, and mitigations. Influence product and technology strategy through market, clinical, and customer insights. Ensure compliance with medical device standards; lead documentation (DHF) and cross-functional collaboration while mentoring and driving high-performance execution.
Requirements
- Bachelor of Science in Software, Electrical, Mechanical, Systems, Biomedical Engineering or related degree & 6+ years of work experience
Nice To Haves
- Proven experience designing, developing, and optimizing complex systems
- Advanced proficiency in requirements management and system modeling methodologies
- Strong ability to communicate complex technical concepts and plans to cross-functional teams
- Hands-on experience with requirements management tools (Jama strongly preferred)
- Experience with SysML and Model-Based Systems Engineering (MBSE) frameworks
- Proficiency with SysML/MBSE modeling tools (e.g., Cameo, MagicDraw, Rhapsody)
- Solid understanding of medical device standards, including ISO 13485 and ISO 14971
Responsibilities
- Lead end-to-end design, development, and evaluation of complex medical device systems
- Apply advanced engineering principles; mentor team members on best practices
- Translate user needs into system requirements and scalable architectures
- Define, decompose, and allocate requirements across multi-disciplinary teams (EE, ME, SW)
- Lead concept phase activities and drive resolution of complex design issues
- Conduct and lead analytical studies (trade-offs, optimization, performance, risk assessments)
- Oversee system integration, verification, and validation activities
- Drive product risk management, including failure analysis, safety requirements, and mitigations
- Influence product and technology strategy through market, clinical, and customer insights
- Ensure compliance with medical device standards; lead documentation (DHF) and cross-functional collaboration while mentoring and driving high-performance execution
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What This Job Offers
Job Type
Full-time
Career Level
Senior
