About the job
The Senior Systems Engineer will spearhead the design and integration efforts for cutting-edge surgical navigation and robotics systems. This pivotal role involves managing the entire product life cycle, from collaborating with marketing to define user needs, conducting early characterization work, and authoring and managing requirements, to executing technical solutions, overseeing verification and validation processes, and facilitating design transfers and complaint investigations. The ideal candidate will excel in collaborating across various engineering disciplines (mechanical, electrical, and software) as well as with other organizational departments (regulatory, marketing, operations, quality, etc.).
Key Responsibilities:
- Define, develop, and enhance system-level accuracy for surgical navigation and robotics platforms, ensuring compliance with clinical, regulatory, and business requirements.
- Author and guide the creation of design, construction, and characterization guidelines for navigated arrays and surgical instruments.
- Lead the integration of complex systems, encompassing mechanical, software, and electrical components.
- Work closely with internal stakeholders (clinical research, marketing, surgeons, etc.) to refine user needs, effectively capturing and articulating user requirements to the engineering team.
- Drive development activities during the concept phase to explore innovative ideas and technologies, ensuring technical readiness for subsequent development stages.
- Develop and implement system and sub-system testing throughout the development phase prior to verification and validation.
- Support compliance testing and product certifications relevant to the system, including IEC 60601-1 testing.
- Demonstrate expertise in ASTM F2554-22.
- Oversee and maintain Design History Files, creating and submitting Change Orders as necessary.
- Establish and maintain product risk management files, facilitating risk-based discussions with other engineering teams.
- Guide the preparation of technical documents for FDA 510(k) submissions or other regulatory filings as required.
- Collaborate with project managers or directly manage projects to ensure timelines are met within budget constraints.
- Lead or assist in Design Control Phase reviews.
- Be a critical resource in driving verification and validation activities, ensuring design documentation is comprehensive for handoff to the V&V team, mentoring in the development of formal testing methods, and proactively addressing testing challenges to foster cross-functional engagement.
- Perform additional duties as assigned.