Senior Systems Engineer

Build a career that makes an impact. At huMannity Medtec, you don’t just build a career, you help change lives. Build a career that makes an impact. At huMannity Medtec, you don’t just build a career, you help change lives. For over 40 years, we have been advancing life-enhancing medical technologies that address unmet healthcare needs. Our teams bring together engineering, science, and clinical expertise to transform bold ideas into solutions that can make a difference for patients around the world. We believe meaningful work and a balanced life go hand in hand. That is why we offer a 9/80 schedule, giving our employees every other Friday off. That means 26 extra long weekends each year to recharge, spend time with family and friends, pursue hobbies, or simply enjoy more balance outside of work. Why huMannity Medtec? Mission-driven work that impacts lives A 9/80 schedule with every other Friday off (26 long weekends a year!) Collaborative teams solving complex challenges Opportunities to learn, grow, and make an impact Donut Thursdays, bagel Fridays, monthly company lunches, and company events that bring us together Here, your work has purpose. Your ideas are valued. Your curiosity is encouraged. Ready to be part of something meaningful? Explore our open opportunities below and join our team! Position Summary We are seeking an experienced Senior Systems Engineer to support the development of advanced medical device technologies from concept through commercialization. As a key member of the Systems Engineering team, this role will collaborate closely with Research & Development, Clinical, Quality, Manufacturing, Software, Electrical, Firmware, and Mechanical Engineering teams to ensure successful product development and system integration. The ideal candidate will have a strong background in systems engineering within a regulated medical device environment and experience translating clinical and business needs into engineering requirements, managing system-level risks, and leading verification and validation activities. This role requires a highly collaborative and self-directed engineer capable of leading multiple projects while ensuring the delivery of safe, effective, and high-quality products. Essential Duties And Responsibilities Translate clinical and customer needs into measurable engineering requirements and ensure traceability through verification and validation activities. Develop and maintain system requirements, specifications, and design documentation. Perform risk management activities in accordance with ISO 14971, including hazard analysis, risk assessments, and mitigation planning. Lead cross-functional system integration efforts involving mechanical, electrical, firmware, software, and sensing technologies. Research, design, develop, prototype, and test system-level solutions. Develop verification and validation plans, protocols, and reports to demonstrate compliance with product requirements and regulatory expectations. Plan and execute system safety and reliability testing activities. Analyze test data and system performance to identify opportunities for improvement and ensure compliance with performance specifications. Collaborate closely with Software, Firmware, Electrical, Mechanical, Quality, Manufacturing, and Clinical teams throughout the product development lifecycle. Support design reviews, root cause investigations, technical assessments, and engineering decision-making. Perform cost and performance analyses for new and existing products. Develop and implement innovative tools, methodologies, and processes to improve engineering efficiency and product quality. Design experiments, test fixtures, and data collection methods to support product development and research activities. Lead multiple engineering projects and ensure timely execution of project deliverables. Required Qualifications Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related engineering discipline. Strong understanding of systems engineering principles and multidisciplinary product development. Experience developing system requirements, specifications, and engineering documentation. Experience performing verification and validation activities within a regulated environment. Knowledge of risk management methodologies and system-level hazard analysis. Proficiency with laboratory test equipment and measurement tools. Strong analytical, problem-solving, and troubleshooting skills. Excellent written and verbal communication skills. Ability to work independently and lead multiple projects simultaneously. Preferred Qualifications Experience in FDA Class III medical device development. Experience with active implantable medical devices. Familiarity with requirements management tools and processes. Knowledge of electronics, embedded firmware, battery-powered systems, RF circuits, sensors, and mechanical systems. Experience with low-power electronic systems. Firmware development experience. Prior experience with system architecture, integration, and reliability engineering. Experience working in a highly regulated medical device environment. Regulatory and Quality System Knowledge ISO 14971 – Medical Device Risk Management ISO 13485 – Medical Devices Quality Management Systems FDA Design Control Requirements (21 CFR Part 820) Active Implantable Medical Device Standards Medical Device Verification and Validation Practices Work Environment Office and laboratory-based engineering environment. Frequent collaboration with cross-functional engineering, quality, manufacturing, regulatory, and clinical teams. Participation in product development activities from concept through commercialization. Fast-paced environment supporting multiple concurrent projects. Physical Requirements Ability to remain in a stationary position while working at a computer and laboratory workstation. Ability to operate laboratory and testing equipment. Ability to communicate effectively with team members and stakeholders. Ability to occasionally move throughout office, laboratory, and manufacturing environments. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position. #J-18808-Ljbffr huMannity Medtec