Technical Oversight Lead – Medical Device Development; Part-Time
Listed on 2026-01-15
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Engineering
Medical Device Industry, Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist
Technical Oversight Lead – Medical Device Development (Part-Time)
A medical technology company developing a regulated wearable device is seeking a highly experienced Technical Oversight Lead to provide senior-level guidance as the program advances through development, manufacturing readiness, and early clinical preparation. This is a part‑time oversight role intended to ensure alignment, clarity, and execution discipline across engineering, manufacturing, and regulatory activities.
This position is not hands‑on engineering. The Technical Oversight Lead serves as an experienced, independent technical authority who reviews work in progress, identifies risks early, and ensures that development activities remain appropriate for a regulated medical device environment. The role exists to prevent misalignment, scope drift, and avoidable rework as the device progresses toward clinical use.
The role places a strong emphasis on communication and judgment. The Technical Oversight Lead must be able to operate comfortably at both the engineering and regulatory levels, translating between disciplines, asking the right questions, and constructively challenging assumptions when necessary. High emotional intelligence is essential, as this role requires influencing outcomes through clarity, credibility, and calm leadership rather than direct authority.
Keyaspects of the role include:
- Providing senior technical and regulatory‑aware oversight across device development, manufacturing planning, and clinical preparation, ensuring work performed by internal teams and external partners remains aligned, well‑coordinated, and execution‑ready.
- Monitoring the Quality Controls and Regulatory Processes and tracking the development processes of a regulated medical device.
- Time commitment is expected to average 5–10 hours per week, with a maximum of 40 hours per month, flexible around key development, manufacturing, and regulatory milestones.
- Compensation is expected to reflect senior advisory‑level engagement and may be structured as hourly consulting fees, monthly retainer, limited equity participation, or a hybrid, depending on experience, availability, and alignment.
The Technical Oversight Lead will review development plans, testing strategies, manufacturing approaches, and documentation practices, offering guidance on design controls, risk management, and development sequencing appropriate for regulated medical devices. The role also includes advising on interactions with regulatory consultants to ensure engineering and testing activities support the intended regulatory pathway.
Ideal candidate profileThe ideal candidate brings substantial experience in regulated medical device development, including exposure to devices advancing toward or into clinical use. Experience with electromechanical or wearable systems is strongly preferred. Candidates must be seasoned professionals who improve outcomes through experience, communication, and sound judgment rather than execution volume.
Conflict‑of‑interest transparency is required. Candidates must disclose any current or planned engagements that could create competitive, regulatory, or intellectual property conflicts. The company values independence of judgment and expects this role to operate with professional integrity and discretion.
This role is best suited for a senior professional seeking a high‑impact, part‑time oversight position where credibility, perspective, and clear communication materially reduce risk and accelerate progress.
Senior level and employment details- Seniority level:
Mid‑Senior level - Employment type:
Contract - Job function:
Health Care Provider - Industries:
Medical and Diagnostic Laboratories
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