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Director of Systems Engineering
2 months ago
We are seeking a highly skilled and experienced Director of Systems Engineering to join our team at Noah Medical. As a key member of our engineering leadership team, you will be responsible for leading the systems engineering team in the development of complex surgical robotic systems.
Key Responsibilities- Lead Systems Engineering Team: Manage and mentor a team of engineering SMEs/leaders to help them realize their full potential.
- System-Level Design Control: Lead and manage system-level design control for one or more complex surgical robotics projects, acting as the liaison and single point of contact for design controls within a large R&D engineering team.
- Requirements Development: Lead and manage requirements development, iteration, release, and maintenance for one or more complex surgical robotics projects.
- Collaboration and Communication: Collaborate with Quality and Regulatory to create and maintain templates, tools, and processes for best-in-class requirements management, and provide guidance on design controls to NPD and PE teams when creating or modifying medical devices.
- Risk Assessment and Management: Lead and manage system-level risk assessments, including the creation and maintenance of system trace matrices.
- Design Reviews and Documentation: Participate in and lead design reviews, FMEA, and other design de-risking and documentation activities.
- Experience: A minimum of 10 years' experience navigating intricate hardware and software environments, with at least 5 years specifically in the field of medical devices.
- Leadership Background: Leadership background, with a minimum of 3 years leading teams in system engineering, and one or more product launches in the medical device space.
- Communication Skills: Strong communication skills to convey concepts and ideas to diverse multi-functional audiences.
- Expertise: Expertise in 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, and IEC 60601.
- Requirements Management Tools: Established proficiency with JAMA or similar requirements management tools.
- Engineering Processes: Established track record of creating and deploying engineering processes for systems engineering, covering requirements, risk, design controls, etc.
- Education: Minimum Bachelor's degree required in Engineering (e.g., Systems, Mechanical, Electrical, Software, Biomedical), Computer Science, or other related field.
- Competitive Salary
- Comprehensive Health Insurance
- Equity and Bonus Program
- Life Insurance and Disability Insurance
- Mental Health Support
- Legal and Pet Insurance
- Paid Holidays and PTO
- Paid Parental Leave
- Learning and Development Opportunities
