Kilele Health Inc. Principal Engineer — Medical Devices Cincinnati, OH · Full time Company website

Apply for Principal Engineer — Medical Devices

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.

Kilele Health Inc.

Cincinnati, Ohio | Onsite | Full-Time

About Kilele Health

Kilele Health is developing a new generation of wearable biosensors for continuous monitoring of biomarkers and chronic diseases that currently rely on intermittent laboratory testing. Our platform combines biosensing, microfabrication, electronics, mechanical systems, and data analytics. Supported by federal and other research and investor funding, we are advancing through product development, clinical studies, and preparation for commercialization.

Key Responsibilities

• Serve as the lead engineer for the development of a mechanically actuated Class II medical-device subsystem.
• Translate user needs and product requirements into engineering requirements, architectures, specifications, and production-intent designs.
• Lead the development of compact mechanisms with reliable, repeatable actuation, incorporating third-party design support as needed and including tolerance analysis, material selection, design reviews, and engineering documentation.
• Iterate rapidly with 3D printing, machining, soft tooling, and other rapid-prototyping methods, while designing for high-volume injection molding, applying design-for-manufacturing, assembly, and reliability principles.
• Contribute to sensor microstrip design, fabrication, handling, assembly, and integration.
• Develop test methods, fixtures, protocols, and acceptance criteria for performance, reliability, and robustness.
• Support design controls, risk management, verification and validation, and design transfer.
• Coordinate external engineering, prototype, tooling, molding, manufacturing, and specialty suppliers as part of the product-development team. Define technical requirements, specifications, deliverables, and acceptance criteria for development partners. Review and challenge supplier designs, analyses, tooling concepts, manufacturing approaches, and recommendations

Potential Areas for Growth

As Kilele grows, this role offers opportunities to deepen your expertise or develop leadership responsibilities. These are possible growth paths, not additional requirements of the initial role.

• Technical specialization in materials, human factors, sterilization, packaging, or reliability.
• Manufacturing and quality expertise through process development, validation, production tooling, or supplier development.
• People leadership through mentoring and, as the team grows, supervision of engineers.

Required Qualifications

• Bachelor’s degree or higher in Mechanical Engineering or a related engineering discipline.
• Substantial experience developing physical products with mechanical components, mechanisms, or assemblies.
• Experience taking a product or major subsystem from concept through detailed design, prototyping, testing, and manufacturing.
• Experience with rapid prototyping and iterative hardware development.
• Experience designing mechanisms that operate reliably across manufacturing and use-condition variability.
• Strong understanding of tolerancing, tolerance stack-up, and mechanical-interface design.
• Ability to develop test methods and use experimental data to guide engineering decisions.
• Strong hands-on engineering and troubleshooting skills.
• Experience working directly with engineering, prototype, tooling, molding, or manufacturing suppliers and managing their technical work while retaining ownership of requirements and design intent.
• Strong written and verbal communication skills and the ability to work in a small, multidisciplinary, fast-moving team.
• Ability to work effectively in a small, multidisciplinary, fast-moving organization.

Particularly Relevant Experience (preferred)

• Design for injection molding, including geometry, tooling, material behavior, tolerances, draft, wall thickness, gating, and manufacturability.
• Autoinjectors, pen injectors, continuous glucose monitor (CGM) insertion devices or applicators, wearable drug-delivery devices, or lancets and blood-sampling devices.
• Needle insertion or retraction, spring-driven or stored-energy mechanisms, and trigger, latch, release, or safety mechanisms.
• Single-use or disposable medical devices, surgical devices or instruments, or other compact, high-volume mechanically actuated medical products.

Highly Desirable Medical Device Experience

• Class II medical-device development.
• FDA design controls and design history files.
• ISO 13485 quality systems.
• ISO 14971 medical-device risk management.
• IEC 62366 human factors/usability engineering.

Why Join Kilele?

Help shape a new category of wearable medical technology while fundamental product and manufacturing decisions are still being made, with equity participation in the upside associated with building a category leader.

You will influence product architecture, mechanical design, materials and manufacturing processes, supplier strategy, development and verification methods, manufacturing transfer, and future engineering hires.

This is a full-time, onsite position in Cincinnati, Ohio. Regular in-person

collaboration with our engineering, biosensor, and development teams is essential.

Kilele Health is an equal opportunity employer. We value diverse backgrounds, perspectives, and experiences and consider all qualified applicants without regard to legally protected characteristics.

Applicants must be legally authorized to work in the United States. Kilele Health is unable to provide employment visa sponsorship for this position.