Director, Medical Device Systems Engineering

The Systems Engineering Lead/Director is a hands-on leader that will guide a team of systems engineers (EE, ME, BME, SWE) in designing, developing, and maintaining complex electromechanical Medical Devices with a strong emphasis on design controls, human factors and usability, requirements traceability, mechanical and electrical reliability testing, controls and software/firmware development. This role involves overseeing cross-functional efforts, ensuring regulatory compliance, and delivering innovative solutions that prioritize patient needs and customer experiences while exceeding industry standards.

Responsibilities including developing and owning system requirements tied to software, mechanical hardware, and electrical hardware and device use along with covering electromechanical hardware, control systems, and software/firmware development, verification, validation, design transfer to manufacturing, hiring, personnel management and adoption of best practices/ tools for the department.

The ideal candidate will have a minimum of 7 years of Systems/EE/ME product development experience and at least 1 year of team leadership with mandatory experience developing mission critical, highly reliable, complex electromechanical products for Medical Device, aerospace, automotive and/or military applications following design control procedures.

• Drive human factors engineering activities, including user research, task analysis, use case scenarios, usability testing, and the development of user interface design specifications.
• Incorporate risk management activities, such as identifying potential use-related hazards, conducting use-related risk assessments, and implementing appropriate risk mitigations.
• Create and maintain a comprehensive requirements traceability matrix, ensuring all design inputs are clearly linked to design outputs, verification, validation activities, and reliability testing.
• Collaborate closely with software and firmware development, EE and ME teams to ensure seamless integration of software/firmware components with hardware systems, adhering to best practices in software engineering and Medical Device software standards.
• Lead the planning and execution of reliability testing, including accelerated life testing, failure mode analysis, and statistical methods to ensure product performance and longevity.
• Facilitate transparent communication between teams and stakeholders, providing regular project updates and addressing any technical or scheduling challenges.
• Cultivate a culture of continuous improvement by staying informed about industry trends, technological advancements, and emerging tools in Medical Device Systems Engineering, human factors, design controls, reliability testing, and software/firmware development.
• Lead the preparation of comprehensive technical documentation, including design inputs, specifications, human factors/usability engineering plans, usability test protocols, reliability test plans, requirements traceability matrix, and technical reports.

• Bachelor’s degree in electrical, mechanical or computer engineering. Advanced degree preferred.
• Proven experience (7+ years) in a regulated industry with a proven track record in Systems Engineering, including project/team leadership and a focus on design controls, reliability testing, software/firmware development, human factors and usability, and requirements traceability.
• 1+ years’ experience leading and managing teams of 3 to 7 individuals.
• Strong grasp of Systems Engineering principles, requirements management, risk management, design controls, human factors engineering, usability, reliability testing, test method development/validation and software/firmware development/validation within a regulated industry, Medical Device preferred.
• Familiarity with human factors engineering processes, usability standards, design controls, test method development for ME/EE/SW engineering, reliability testing methodologies, software development and testing practices, and governing regulations.
• Exceptional interpersonal and communication skills, with the ability to foster a collaborative team culture, collaborate effectively across diverse disciplines, and must be able to influence decision-making.
• Demonstrated track record in driving results, managing complex projects, nurturing team culture, and adapting to shifting priorities within a dynamic fast paced environment.
• Successful history of launching and maintaining products in the field within a regulated industry
• Functional management of system engineering team including team member recruiting, hiring, mentoring, professional development, and performance reviews