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 Requirements 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 Core Competencies 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. Highest-signal resume keywords Medical Imaging System Development Regulatory Compliance Project Management Risk Management (ISO 14971) Team Leadership ATS Optimization Keywords Hard Skills 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 Soft Skills Excellent Communication Skills Strong Interpersonal Skills Analytical Skills Organizational Skills Problem-Solving Skills Industry Keywords Medical Device FDA Audits ISO Audits Phase-Gate Product Development Contract Manufacturing #J-18808-Ljbffr Jobtailor