Kilele Health Inc. Head of Biosensor Development Cincinnati, OH · Full time Company website

Apply for Head of Biosensor Development

Kilele Health is building the next generation of wearable biosensors—bringing continuous, real-time monitoring to important biomarkers beyond glucose. Most patients and clinicians still make critical treatment decisions using laboratory measurements taken only occasionally—a snapshot of biology that is constantly changing. Kilele Health is working to change that. We are developing a wearable biosensor platform that continuously monitors medically important biomarkers beyond glucose, helping make care more timely, personalized, and proactive. Our proprietary platform combines advanced aptamer chemistry, electrochemical sensing, and a familiar wearable form factor to give patients and clinicians access to biochemical information that today requires intermittent laboratory testing. Our first products are aimed at patients with phenylketonuria and cardiorenal disease, where better information could meaningfully improve treatment and outcomes, with a broader vision of making previously invisible health signals measurable and actionable. Joining Kilele means helping build a new kind of healthcare technology while working alongside a multidisciplinary team united by scientific rigor, urgency, and a commitment to patients. We are assembling an exceptional team of scientists, engineers, clinicians, and business leaders who want to help turn breakthrough technology into products that meaningfully improve patients’ lives.

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!

About Kilele Health

Kilele Health is building the next generation of wearable biosensors—bringing continuous, real-time monitoring to important biomarkers beyond glucose. Most patients and clinicians still make critical treatment decisions using laboratory measurements taken only occasionally—a snapshot of biology that is constantly changing. Kilele Health is working to change that.

We are developing a wearable biosensor platform that continuously monitors medically important biomarkers beyond glucose, helping make care more timely, personalized, and proactive. Our proprietary platform combines advanced aptamer chemistry, electrochemical sensing, and a familiar wearable form factor to give patients and clinicians access to biochemical information that today requires intermittent laboratory testing.

Our first products are aimed at patients with phenylketonuria and cardiorenal disease, where better information could meaningfully improve treatment and outcomes, with a broader vision of making previously invisible health signals measurable and actionable. Joining Kilele means helping build a new kind of healthcare technology while working alongside a multidisciplinary team united by scientific rigor, urgency, and a commitment to patients. We are assembling an exceptional team of scientists, engineers, clinicians, and business leaders who want to help turn breakthrough technology into products that meaningfully improve patients’ lives.

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 Development is 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.