Systems Engineer - Medical Device Company

Job Description

Job Description

About Mitovation

Mitovation is a clinical-stage medical device company developing a near-infrared photobiomodulation (NIR-PBM) therapy that protects the brain from reperfusion injury after cardiac arrest. The technology originated from mitochondrial biology research at Wayne State University and the University of Michigan and has progressed through an active FDA Investigational Device Exemption (IDE) and a pediatric clinical study. This position is funded through Mitovation's NIH Cooperative Agreement grant.

Position Summary

The Systems Engineer will be one of the first engineering hires at Mitovation, helping stand up a new company office in the Ann Arbor/Detroit, MI area. This role owns system-level architecture, integration, and verification across hardware, firmware, optics, and software subsystems, and works directly with Mitovation's external manufacturing partners to assist with the build of the clinical study systems used at trial sites.

Key Responsibilities

Clinical system support:

• Own system-level builds and testing for the clinical study device platform, working with our manufacturing partner.

• Support IDE maintenance and contribute engineering documentation supporting the clinical study.

New system design / development:

• Translate clinical and user needs into system, subsystem, and component-level technical requirements, and maintain traceability through the design history file.

• Lead system integration across electrical, mechanical, optical, firmware, and software subsystems, coordinating with the manufacturing partner throughout the build process.

• Develop and execute verification and validation (V&V) test protocols; author associated technical reports.

• Support risk management activities (FMEA, hazard analysis) in accordance with ISO 14971 and Class II medical device design controls.

• Help stand up engineering processes and documentation at the new company office as an early technical hire.

• Support buildout of a Quality Management System (QMS) in anticipation of future ISO 13485 certification.

Required Qualifications

• Bachelor's degree in Biomedical, Electrical, Mechanical, or Systems Engineering (or related field); advanced degree a plus.

• 5+ years of systems engineering experience in medical devices, with direct experience in design controls (21 CFR 820.30 / ISO 13485).

• Demonstrated experience taking a device from prototype/early clinical stage through design V&V.

• Working knowledge of risk management standards (ISO 14971) and IEC 60601 electrical safety requirements for medical electrical equipment.

• Comfort working in a small-company, early-stage environment — willing to be hands-on with builds and testing as well as documentation and process.

• Strong cross-functional communication skills; able to work directly with founders, clinical partners, and the external manufacturing partner.

Preferred Qualifications

• Experience with optical or light-based therapeutic devices (photobiomodulation, phototherapy, laser/LED systems).

• Experience working alongside a contract manufacturer or external build partner on clinical or early-production device units.

• Familiarity with FDA IDE and De Novo/510(k) regulatory pathways.

What Mitovation Offers

• The opportunity to build the engineering foundation of a company developing a first-in-category neuroprotection therapy, with FDA IDE already in hand and an active clinical study underway.

• A seat at the table during a pivotal growth phase — this hire directly shapes the technical team and the new company office.

• Competitive salary and benefits, commensurate with an early-stage medical device company.

\nCompany Description

Mitovation is a Michigan based medical device startup company with their first product treating post cardiac arrest re-perfusion injury.
Why is this a breakthrough? Cardiac arrest impairs systemic perfusion and renders the brain and other organs ischemic. The brain is highly reliant on a constant supply of oxygen and nutrients and thus is particularly sensitive to the resultant deficit in blood flow. In the absence of rapid resuscitation and restoration of blood flow, ischemia leads to severe neurologic damage. While resuscitation is required to preserve neurologic function, it also initiates re-perfusion injury, which plays a major role in the compromised recovery of resuscitated patients, and is thought to contribute significantly to the high incidence of morbidity and mortality associated with cardiac arrest. Despite advances in cardiopulmonary resuscitation, neurological function – a primary metric for clinical outcome – remains poor following cardiac arrest and resuscitation.

Mitovation has developed a breakthrough technology to prevent the brain damage that occurs from a cardiac arrest.

Company Description

Mitovation is a Michigan based medical device startup company with their first product treating post cardiac arrest re-perfusion injury. \nWhy is this a breakthrough? Cardiac arrest impairs systemic perfusion and renders the brain and other organs ischemic. The brain is highly reliant on a constant supply of oxygen and nutrients and thus is particularly sensitive to the resultant deficit in blood flow. In the absence of rapid resuscitation and restoration of blood flow, ischemia leads to severe neurologic damage. While resuscitation is required to preserve neurologic function, it also initiates re-perfusion injury, which plays a major role in the compromised recovery of resuscitated patients, and is thought to contribute significantly to the high incidence of morbidity and mortality associated with cardiac arrest. Despite advances in cardiopulmonary resuscitation, neurological function – a primary metric for clinical outcome – remains poor following cardiac arrest and resuscitation.\n\nMitovation has developed a breakthrough technology to prevent the brain damage that occurs from a cardiac arrest.