Senior Systems Engineer

Job Description

• 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

Qualifications

• 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

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