Director, Systems Engineering jobs in United States
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Presidio Medical, Inc. · 4 months ago

Director, Systems Engineering

Presidio Medical, Inc. is seeking a Director of Systems Engineering responsible for overseeing the systems engineering function for complex medical devices. The role involves managing the entire system life cycle, from stakeholder requirements to design and validation, while leading a team of systems engineers and fostering innovation.

Developer PlatformInformation TechnologyMedicalSoftware
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Systems engineeringMedical device developmentProject managementRisk management (ISO 14971)Usability engineering (ISO 62366)Leadership skillsCommunication skillsProblem-solving abilitiesTeam collaboration

Required

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
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
Bachelor's degree in engineering

Preferred

Advanced degree preferred

Company

Presidio Medical, Inc.

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We are a clinical-stage, privately held medical technology company developing a transformational neuromodulation platform to treat diseases of undesired neural activity.

H1B Sponsorship

Presidio Medical, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)

Funding

Current Stage
Growth Stage
Total Funding
$102M
Key Investors
DeerfieldInvus OpportunitiesAction Potential Venture Capital
2023-06-26Series C· $72M
2020-07-14Series B· $30M
2018-01-01Series A

Leadership Team

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Michael Onuscheck
CEO and Chairman
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Kenneth Wu
Co-founder & Board Member
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Company data provided by crunchbase