Head of Engineering

Employment Type: Full-Time, Exempt

Reports To: Chief Executive Officer (CEO)

Summary

AesculaTech is a clinical-stage startup built around a shared vision: that smart, environmentally responsive materials can personalize products and change lives. Our first-in-class treatment for dry eye disease, Humidifeye, recently received IDE approval and is entering pivotal clinical trials — a major milestone toward commercialization. Our engineering team needs a new leader to spearhead manufacturing efforts and lead our development process as we grow our product pipeline.

In the near term, the Head of Engineering is responsible for the successful build of investigational devices for our upcoming pivotal trial, working closely with our clinical team and manufacturing partners. The role will also lead Design for Manufacturing (DFM) in parallel, managing a small team of mechanical engineers to reduce costs and prepare the product for transfer to a mid-to-large volume contract manufacturer. A background in medical products is required as the Head of Engineering will need to understand the regulatory implications of device changes and will serve as the key point of contact for future regulatory submissions. An experienced understanding of quality control systems, cGMP manufacturing, mechanical engineering, and medical product development are essential for success.

This is a leadership position that works directly with the CEO. Strong communication skills, a high degree of professionalism, and a versatile technical foundation are required. AesculaTech is a small startup, and this person will be expected to independently solve problems, wear multiple hats, and keep the device program moving forward across clinical, engineering, manufacturing, and regulatory functions. Success in this role will reward you with the opportunity to take a first-in-class medical device from pivotal trial through commercial scale, and to play a defining leadership role in a fast-growing medtech startup.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degree preferred.
• 6+ years of experience in medical device R&D/product development and manufacturing, with direct experience in both functions.
• Demonstrated experience with Design for Manufacturing (DFM) and design transfer from low-volume to mid- or high-volume contract manufacturing.
• Experience selecting, negotiating with, and managing parts vendors or contract manufacturers (CMs/CMOs).
• Working knowledge of design controls, risk management (ISO 14971), and quality management systems (ISO 13485/21 CFR 820).
• Experience supporting medical device regulatory submissions (e.g., IDE, 510(k), PMA), in partnership with regulatory affairs experts.
• Prior experience in a startup or small-company environment, with the ability to operate with significant autonomy across multiple functions.
• Experience managing and developing a technical team.
• Strong communication and interpersonal skills, with the ability to work effectively across clinical, engineering, manufacturing, and regulatory stakeholders.
• Organized, highly motivated, and capable of working independently.
• Serve as the primary technical lead for the Humideye device.
• Act as the technical liaison for AesculaTech's clinical team, work closely with contract manufacturing partners for the build of investigational devices supporting the upcoming pivotal trial.
• Provide day-to-day technical direction and oversight to the manufacturing engineer, ensuring investigational device builds meet design specifications, quality standards, and trial timelines.
• Troubleshoot design, process, and quality issues that arise during investigational device production, and drive timely resolution with the manufacturing partner.
• Support the clinical team on device-related questions, dependencies, and readiness ahead of pivotal trial start.
• Lead Design for Manufacturing (DFM) efforts to prepare Humidifeye for scaled, reliable production.
• Own and execute design transfer from our current manufacturing partner to a mid-to-large volume contract manufacturer.
• Identify, evaluate, and manage relationships with contract manufacturers and key suppliers, including scope, quality, cost, and timeline negotiations.
• Serve as the key point of contact on the device for future regulatory submissions, partnering closely with AesculaTech's external regulatory consulting firm.
• Own and maintain device-related design control documentation, the Design History File (DHF), risk management files, and related QMS records.
• Build out and manage the device engineering/manufacturing function, including hiring, onboarding, and managing the current manufacturing engineer and future hires.
• Provide regular updates on device development, manufacturing status, risks, and timelines to the CEO.
• Represent Humidifeye's device and manufacturing function in cross-functional and external conversations, including with investors and strategic partners as needed.
• Support the growth and development of AesculaTech as a whole, contributing to projects or processes that are important for the company even if they are not covered by the responsibilities listed above.

Desirable Qualifications

• Experience with ophthalmic or other implantable/wearable/injectable medical devices.
• Experience supporting a pivotal clinical trial.
• Familiarity with medical sealants or drug-device combination products.
• Experience scaling a device program from early clinical-stage manufacturing through commercial launch.
• Base salary commensurate with experience
• Equity
• Medical, dental, and vision insurance
• 401(k)

Position Point of Contact

About AesculaTech

AesculaTech was founded to bring revolutionary materials to the medical device industry. Imagine a product that can adapt to your body — taking its shape or hardening on contact. Our team specializes in the design of molecules that make this possible. Using chemical engineering, we create intelligent materials with tunable responses to their environment. The first of their kind, these smart materials offer next-generation products in healthcare, consumer products, and beyond. Please visit our website at aesculatech.com to learn more!

An award-winning startup, AesculaTech was named a Rosenman Innovator by the Rosenman Institute, for its pioneering medical device development, and participated in the accelerator programs Y Combinator and TMCx. We are led by one of MIT Tech Review's 35 Innovators Under 35.

AesculaTech is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.