Senior Systems Engineer

About The Team:

The Systems Engineer will be responsible for to translate customer requirements into detailed product requirements and following through all design control phases of the product. The Systems Engineer 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 Systems Engineer

• System Architecture and Risk Management: Define and oversee the architecture, requirements, and risk management for complex surgical robots.
• Cross-functional collaboration: Work with cross-functional teams to create test strategies and ensure that design inputs are verifiable and testable.
• Methodologies and Standards Improvement: Contribute to the definition and enhancement of Systems Engineering methodologies and standards.
• Requirements and Risk Analysis: Establish requirements and risk analysis deliverables for surgical robots and related subsystems.
• Verification and Testing: Develop verification test methods, maintain and execute test protocols, conduct tests and experiments, and analyze data to validate system performance and identify risks.
• Reporting and Decision Guidance: Create comprehensive reports to summarize results and lead cross-functional discussions to navigate tradeoff decisions, balancing customer and business benefits with technical complexity, safety, and schedule risks.

About You

• A minimum of 4 years experience navigating intricate hardware and software environments, with at least 2 years specifically in the field of medical devices or other regulated industries
• 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.
• Work collaboratively and efficiently in a fast-paced start-up with minimal supervision.
• Ability to work independently, and the determination to get through challenging problems.
• Exceptional Communication and Leadership: Demonstrate strong communication skills and lead cross-functional engineering teams to ensure effective collaboration.

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