Head of Biosensor Development

Kilele Health Inc.; Cincinnati (OH); On-site; USD 180,000 - 280,000; Full time

Job summary

Kilele Health Inc. seeks a Head of Biosensor Development to lead the electrochemical microstrip sensing element for wearable biosensors. This role partners with hardware/software to translate concepts into manufacturable products.

You will supervise design verification/validation, ensure quality and regulatory readiness, manage risks and budgets, and drive cross-functional collaboration for scalable manufacturing.

Qualifications

• Formal education in a related engineering field with advanced degree or equivalent experience.
• Demonstrated leadership developing Class II or higher electrochemical sensors from concept through manufacturing transfer.
• Experience within a regulated medical device quality system.

Responsibilities

• Define the sensor development strategy and roadmap from plated electrodes to transmitter integration.
• Lead and mentor a multidisciplinary sensor development team.
• Oversee verification, validation, and manufacturing readiness activities.

Skills

Leadership

Electrochemical sensing

Cross-functional collaboration

Regulatory experience

Project management

Education

PhD in Biomedical Engineering, Materials Science, Chemical Engineering, Electrical Engineering, Mechanical Engineering, or related field

MS in a relevant field with 10+ years of experience

BS with exceptionally relevant work experience

Tools

Sensor manufacturing processes

Dried reagent chemistries

Voltammetry/Amperometry

Electrochemistry

Job description

Head of Biosensor Development

Must Haves for this Position

• Formal education in Biomedical Engineering, Materials Science, Chemical Engineering, Electrical Engineering, Mechanical Engineering, or a related field with a substantial combination of degree level (BS/MS/PhD) and relevant work experience
• Demonstrated leadership developing Class II or higher electrochemical sensors from concept through manufacturing transfer, including direct expertise in one or more elements of electrochemical sensing (e.g. electrochemistry, sensor manufacturing processes, biomaterials, dried reagent chemistries, voltammetry/amperometry).

While we always appreciate interest in our Company, if you do not meet the above criteria, we urge you to spend your efforts on a role with a higher probability of success for you, thanks!

The Position

The Head of Biosensor Development leads the development of Kilele Health's wearable biosensor sensing element – the electrochemical microstrip with active reagent chemistry present. This role will work closing with the Head of Hardware/Software to create fully developed wearable biosensors based on regenerative aptamer chemistries.

The Head of Biosensor Developmentis responsible for the design, development, verification, validation, and manufacturing readiness of the microstrip sensing element subsystem, ensuring it meets performance, quality, reliability, and scalability objectives. Working closely with aptamer development, electronics, manufacturing, quality, regulatory, and clinical, this role translates innovative sensor concepts into robust, manufacturable products.

Leadership & Strategy

• Define and execute the technical strategy and development roadmap for the sensor subsystem from plated electrodes through transmitter integration.
• Build, lead, mentor, and develop a multidisciplinary sensor development team while fostering a culture of innovation, collaboration, accountability, and technical excellence.
• Establish development priorities, resource plans, and departmental budgets aligned with product development objectives.
• Manage technical risks, development timelines, and project execution to achieve key milestones on time and in budget.
• Evaluate emerging materials, manufacturing methods, and technologies to improve sensor performance, manufacturability, and reliability.

Sensor Development

• Lead the development and optimization of sensor manufacturing methods, test procedures, and assembly processes.
• Develop process controls and strategies that improve consistency, yield, quality, and scalability.
• Support sensor prototype builds as needed.
• Partner with Manufacturing to ensure successful technology transfer and continuous process improvement.
• Lead investigations into sensor performance issues and implement corrective actions that improve product robustness and manufacturability.

Verification, Validation & Manufacturing Readiness

• Define and oversee verification and validation strategies for the sensor subsystem.
• Develop quality control methods, reliability testing protocols, and performance characterization strategies.
• Ensure development activities support design controls, quality system requirements, and regulatory submissions.

Cross-Functional Development

• Collaborate with aptamer development, electronics, manufacturing, quality, regulatory, and clinical teams to deliver integrated product solutions.
• Partner with systems and electronics engineers to optimize sensor performance through transmitter integration.
• Analyze experimental, manufacturing, and clinical data to guide design decisions, process improvements, and product performance.
• Communicate technical strategy, project status, risks, and resource needs to executive leadership to support strategic planning and decision-making.

Technical Qualifications

Required

• Ph.D. in Biomedical Engineering, Materials Science, Chemical Engineering, Electrical Engineering, Mechanical Engineering, or a related field with 5+ years of relevant industry experience; or M.S. with 10+ years of experience. B.S. with exceptionally relevant work experience will be considered.
• Demonstrated leadership developing Class II or higher electrochemical sensors from concept through manufacturing transfer, including direct expertise in one or more elements of electrochemical sensing (e.g. electrochemistry, sensor manufacturing processes, biomaterials, dried reagent chemistries, voltammetry/amperometry).
• Experience developing products within a regulated medical device quality system.
• Experience leading cross-functional product development teams in a fast-paced R&D environment.
• Strong understanding of design controls, verification, validation, risk management, and manufacturing readiness.
• Experience with project management, budget management, and personnel management.

Preferred

• Experience developing continuous monitoring sensors (CGM or analogous electrochemical wearable sensors, e.g. wearable or implantable).
• Experience with statistical analysis and Design of Experiments (DOE).
• Experience supporting clinical studies and regulatory submissions.
• Experience scaling manufacturing processes from prototype through commercial production.