Director, Systems Engineering

Job Description

• 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

Qualifications

• 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, 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

Benefits

• Competitive Salary • Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options • Equity & Bonus Program • Life Insurance (company paid & supplemental) and Disability insurance • Mental health support through medical insurance programs • Legal and Pet Insurance • 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days • Paid parental leave • In-office snacks and beverages • In-office lunch stipend • Learning & Development Opportunities: On-demand online training and book reimbursement • Team building and company organized social and celebration events