Director, Systems Engineering

About the Company

At Presidio Medical, we are transforming the way neuromodulation balances the human nervous system and are striving to end the cycle of unnecessary pain and help patients live their best lives.

Presidio’s Ultra Low Frequency (ULF™) Neuromodulation System blends innovative circuit design, computational modeling, material science advancements and expertise in neuroscience and electrochemistry. Our therapy is designed to target localized pain by reducing neuronal responses.3 Suppression of these signals may ease pain for some patients suffering from nociceptive pain.

Our focus is to break the cycle of constrained thinking about chronic nociceptive pain. Our goal is to create a world with less suffering — one that may offer relief to patients who have had limited therapeutic options.

About the Role

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, electrical engineering and a track record of successful project management, as well as people leadership experience.

What you will do

• 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.

What you bring

• Minimum 10 years of experience in systems engineering in medical devices.
• Bachelor's degree in engineering; advanced degree preferred.
• Electrical Engineering experience required.
• 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.

Required Skills

• 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.

Pay range is $230,000 - $260,000

Position is Hybrid, based in San Mateo.

Equal Opportunity Statement

We are committed to diversity and inclusivity.