JOB SUMMARY

The Director, Systems Engineering will be responsible for the systems engineering function for complex medical devices. This position requires knowledge of the technical processes of medical device systems engineering to cover the whole system life cycle. Responsibilities include determining stakeholder needs and requirements, systems requirements architecture, design, implementation, integration, verification and validation processes. This role requires a strong background in medical device development, systems engineering principles, and a track record of successful project management.

EXPERIENCE

• Minimum 10+ years of experience in systems engineering in medical devices.
• Experience in neuromodulation is a must, preferably in spinal cord stimulation.
• 5+ years of experience managing and leading teams.
• In-depth knowledge of complex active implantable medical device system design.

KNOWLEDGE/SKILLS/ABILITIES

Required

• Strong understanding of medical device development processes, regulations, and quality standards
• Proven track record of successfully managing complex, cross-functional projects from initiation to completion.
• Excellent leadership, communication, and interpersonal skills.
• Exceptional problem-solving abilities and the capacity to make decisions under pressure.
• Outstanding communication skills, including presentation and written communications.
• Ability to work in a fast-paced, team environment, meet deadlines, and prioritize and balance work for multiple individuals.
• Intrinsically motivated, and detail oriented with profound problem-solving abilities

Education

• Bachelor’s degree in engineering; advanced degree preferred.

• Participate and guide system design and development at all stages of the development lifecycle where the scope of responsibilities require integration of multiple disciplines and departments.
• Use Systems Engineering methods and tools to develop systems engineering products such as requirements decomposition, system architecture; specifications, systems engineering and program plans, interfaces, risk assessment and mitigation, validation and verification planning, overall integration, etc.
• Apply interdisciplinary, collaborative approaches to plan, coordinate, design, develop and verify complex systems solutions to drive integration of hardware and software components ensuring seamless functionality and performance.
• Create departmental strategies and specific objectives and develop budgets, policies, and procedures.
• Lead, coach, and manage a team of systems engineers, providing guidance and driving best practices.
• Foster a culture of innovation, collaboration, and continuous improvement.
• Deep knowledge of risk management processes according to ISO 14971 as well as usability engineering process according to ISO 62366.
• Collaborate with cross-functional teams to drive strategies to execution and ensure system-level requirements are met and seamless functionality and performance.
• Lead definition and coordination of system performance requirements and technical parameters.
• Define system architecture solutions by working with diverse disciplines including ME, EE, Firmware, and Software teams, ensuring scalability, reliability, and performance.
• Develop verification & validation master test plans and oversee internal and external testing efforts to ensure user needs as well as product requirements are met.
• Responsible for the technical reviews, key milestone gating, and follow ups