What You Will Do
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
What You Need (Minimum Required Qualifications)
Bachelor of Science in Software, Electrical, Mechanical, Systems, Biomedical Engineering or related degree & 6+ years of work experience
Preferred Qualifications (Strongly desired)
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
$102,600 - $171,000 USD Annual
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