Senior Systems Engineer
- Louisville, CO
- $120,000-140,000 per year
- Permanent
- Full-time
- 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.
- 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.
- 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.