Senior Systems Engineer

• Lead cross-functional project teams in designing and developing medical imaging systems from concept to launch through the phase-gate product development process
• Ensure products and processes comply with applicable industry guidance, standards, and regulations
• Work with clinicians, end users, and marketing to define and evaluate innovative product concepts addressing customer and business needs
• Support sustaining engineering initiatives for strategic products manufactured in-house or at contract manufacturing sites
• Support program management by managing technical product deliverables and Design History Files (DHF)
• Monitor project progress, manage critical-path activities, and ensure adherence to milestones and timelines
• Communicate project status through verbal and written reports to Senior Management
• Facilitate engineering change request quorum to manage project scope and defects
• Work with Quality and Regulatory Affairs on new-product regulatory activities, including country registrations and 510(k) submissions and follow-up
• Respond to internal and external audits, including FDA and ISO audits
• Participate in post-market investigations as needed

• Undergraduate degree in an engineering or science discipline, including Biology, Biomedical Engineering, Chemistry, Chemical Engineering, Material Science, Mechanical Engineering, or another related discipline
• Minimum of 7–9 years of R&D experience
• Proven track record leading teams of Systems, BME, SW-E, ME, and/or EE engineers
• Experience developing and commercializing products within a regulated industry, preferably medical imaging
• Ability to understand clinical scenarios and conceptualize technical solutions
• Ability to explain concepts to implementation engineers
• Ability to test and evaluate designs and prototypes
• Knowledge of medical device risk management per ISO 14971 preferred
• Experience designing products and processes per industry standards
• Exposure to medical device safety standards such as IEC 60601-1 highly desired
• Ability to lift 25 lbs with or without accommodations
• Excellent written and verbal communication skills
• Strong interpersonal skills
• Strong analytical and organizational skills
• Ability to work in a fast-paced, small-team environment with minimal direction
• Ability to handle open-ended problems and ambiguity

Demonstrates expertise in leading cross-functional teams to design and develop medical imaging systems while ensuring compliance with industry standards and regulations. Proficient in managing technical deliverables, project timelines, and facilitating communication among stakeholders.

• Medical Imaging System Development
• Regulatory Compliance
• Project Management
• Risk Management (ISO 14971)
• Team Leadership

• R&D Experience
• Product Commercialization
• Design History Files (DHF)
• Clinical Scenario Analysis
• Prototyping and Testing
• Medical Device Safety Standards (IEC 60601-1)
• Engineering Change Management

• Excellent Communication Skills
• Strong Interpersonal Skills
• Analytical Skills
• Organizational Skills
• Problem-Solving Skills

• Medical Device
• FDA Audits
• ISO Audits
• Phase-Gate Product Development
• Contract Manufacturing