The Sr Systems Engineer will lead design and development integration efforts related to surgical Navigation and Robotics. The successful candidate will be responsible for driving systems through their entire life cycle, collaborating with Marketing to refine user needs, early characterization work, requirements authoring and management, technical execution, verification and validation, design transfer, and complaints investigations. This role is for a successful collaborator between functional engineering disciplines (mechanical, electrical, and software) and other departments within the organization (regulatory, marketing, operations, quality, etc.).

Essential Duties and Responsibilities

• Define, develop, and optimize system level accuracy for surgical navigation and robotics platforms, ensuring alignment with clinical, regulatory, and business needs.

• Author and direct guidelines for the design, construction, and characterization of navigated arrays and surgical instruments.

• Lead the integration of complex systems, including mechanical, software, and electrical sub-systems.

• Collaborate with business and other internal stakeholders (clinical research, marketing, surgeons, etc.) to refine user needs, with emphasis on capturing and articulating user requirements effectively to the team.

• Drive concept phase development activities to explore ideas and new technologies, ensuring technical readiness to enter development stages of the system life cycle.

• Develop and execute system and sub-system tests through development prior to verification and validation.

• Manage or support compliance testing and product certifications relevant to the system of interest, such as: IEC 60601-1 testing.

• Be an expert in ASTM F2554-22.

• Oversee and maintain Design History Files, create and submit Change Orders.

• Create and maintain product risk management files and facilitate risk-based conversations with other functional engineering groups.

• Guide and author technical inputs for FDA 510(k) submission development or other regulatory filings as assigned.

• Work closely with a project manager, or directly manage projects as appropriate, to drive clear timelines that are executed on time and on budget.

• Lead or support the execution of Design Control Phase reviews.

• Be a key resource in driving verification and validation activities: be responsible for ensuring design documentation is clear and complete for hand off to a V&V team; be a coach and mentor in developing formal test methods to support the V&V team; articulate testing challenges and needs early in the system life cycle to drive cross-functional engagement.

• Other duties as assigned.

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• BS Degree in Engineering – Computer, Electrical, Mechanical, Systems or related discipline. Advanced degree desirable.

• INCOSE certified systems engineer desirable.

• Certified Scrum Alliance product owner desirable.

• Understanding of medical device product life cycles.

• Understanding of software development processes.

• Good understanding of requirements testing and traceability methodology within the system development life cycle.

• Experience with design control processes.

• Demonstrated discipline and professionalism to work within published FDA device regulatory guidelines and rigorously follow internal Standard Operating Procedures, including documentation of the testing procedures and results

• Proven experience as a cross-functional leader.

Education and Experience

• Undergraduate degree in an engineering discipline, graduate degree preferred.

• Minimum 5 years of experience in product development, medical device engineering, etc.

• At least 2-3 years working as a systems engineer or related roles working with FDA/GMP requirements, knowledge of EMC & Compliance testing, software development life cycle, design control processes, and cross-functional product development team experience.