A Day In The Life Of Our Sr. Manager, Systems Engineering
- Manage and mentor engineering SMEs/leaders within the systems team to help them realize their full potential.
- Lead and manage system-level design control for one or more complex surgical robotics projects. Act as the liaison and single point of contact for design controls within a large R&D engineering team.
- Lead a cross-functional systems engineering team that contributes to new product development (NPD) and product engineering (PE) for complex medical robotic systems.
- Provide guidance on design controls to NPD and PE teams when creating or modifying medical devices.
- Lead and manage requirements development, iteration, release, and maintenance for one or more complex surgical robotics projects.
- Collaborate with Quality and Regulatory to create and maintain templates, tools, and processes for best-in-class requirements management.
- Lead and manage system-level risk assessments, including the creation and maintenance of system trace matrices.
- Participate in and lead design reviews, FMEA, and other design de-risking and documentation activities.
- Work collaboratively across cross-functional teams in a startup environment with minimal supervision and guidance.
About You
- A minimum of 7 years' experience navigating intricate hardware and software environments, with at least 5 years specifically in the field of medical devices.
- Leadership background, with a minimum of 3 years leading teams in system engineering. One or more product launches in the medical device space
- Strong communication skills to convey concepts and ideas to diverse multi-functional audiences.
- Expertise in 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1
- Established proficiency with JAMA or similar requirements management tools.
- Established track record of creating and deploying engineering processes for systems engineering, covering requirements, risk, design controls, etc.
- Minimum Bachelor's degree required in Engineering (e.g., Systems, Mechanical, Electrical, Software, Biomedical), Computer Science, or other related field.
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