Director, Systems Engineering

About The Team:

The Systems Engineering Director will be responsible for leading the systems engineering team dedicated to translating customer requirements into detailed product requirements and following through all design control phases of the product. The Systems Engineering Manager will also manage risk assessment and traceability of system level requirements of a complex surgical robotic system and create documentation required for regulatory submissions. They will also guide customer and product requirements, develop and document system architecture, and perform system evaluations on new clinical indications as needed. We are looking for a self-motivated, well rounded individual willing to take ownership and operate with minimal supervision in a fast paced startup environment.

A Day In The Life Of Our Director, 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 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.

Workplace Type: Hybrid

Benefits & Perks (For Full Time Employees):

• 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

#LI-Hybrid