Systems Architect​/Program Director - Neuromodulation

Principal/Director level Lead Systems Architect - Implantable Neuromodulation - Twin Cities

Location:

Minneapolis‑St. Paul Metro Area (starts remote while office location is finalized)

Seniority:
Principal to Director level (open seniority; deep technical experience required)

A well‑funded early‑stage medical device company is developing a first‑generation implantable neuromodulation system for a large, underserved neurological condition. The company has licensed key components of a clinically validated platform, creating a substantial technical foundation while still leaving important system‑level engineering and integration work ahead.

This is one of the first hires at the company. At the moment, only the CEO is in place. The Systems Lead will immediately become a core technical leader, shaping both system architecture and program execution as the company advances toward clinical trials.

This position combines program leadership with system architecture. The role involves guiding system‑level technical direction while also contributing hands‑on to architecture definition, requirements development, integration, verification planning, and cross‑functional coordination.

The Systems Engineer will take responsibility for system architecture, system requirements, trade studies, and integration across electrical, mechanical, firmware, and software elements. The role also involves coordination with external design and manufacturing partners, as well as alignment with clinical, regulatory, and quality functions. This is a broad technical role where your decisions will directly influence the readiness of a Class III implantable device entering the clinical stage.

• Licensed technology provides a strong starting point, reducing risk and accelerating development
• The therapy has a clear clinical rationale and established reimbursement environment
• The remaining work centers on focused, high‑impact engineering challenges
• The company expects a faster‑than‑typical PMA development timeline
• Early employees receive meaningful equity at an advantageous valuation
• Hybrid work structure available while the company finalizes its Twin Cities office location
• As one of the first hires, you will have substantial influence and visibility

• Lead system architecture and system‑level design considerations
• Create system requirements, specifications, and risk documentation
• Coordinate integration across implant hardware, firmware, software, and external components
• Build and maintain system documentation and support DHF development
• Develop and support system‑level verification and validation plans
• Collaborate with contract engineering and manufacturing partners
• Work with regulatory, clinical, and quality teams on system deliverables
• Provide system status updates and recommendations to leadership

• 10+ years of medical device development experience
• At least five years specifically in systems engineering technical/functional leadership roles
• Experience with active implantable devices or neuromodulation platforms
• Strong understanding of electrical and electromechanical system behavior
• Experience with requirements development, risk management, and verification planning
• Familiarity with standards such as ISO 14708, ISO 14971, IEC 60601, and ISO 10993
• Experience working with external engineering and manufacturing partners
• Clear communication skills and comfort operating with broad ownership

• Principal to Director/VP level systems engineers from other med tech OEMs in the implantable device space - some startup exp is preferred
• Senior systems engineers seeking a broader role than a large company can offer
• Engineers who want to see their decisions directly influence program direction and clinical readiness
• Individuals who thrive in a small, hands‑on team environment

Competitive base salary aligned to Principal or Director levels, early‑stage stock options, medical benefits, PTO, and 401(k). Additional equity grants may be available as the company progresses.

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct‑hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.