This range is provided by Cambridge Recruiters. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base Pay Range
$180,000.00/yr - $210,000.00/yr
Additional Compensation
Annual Bonus and Stock options
Company & Product Info
Well-funded medical device startup (~5 people) developing a Class III Active Implantable cardiac diagnostic system for heart failure. The platform includes a catheter-based delivery system and a Nitinol implant with integrated sensors and electronics.
Funding & Status
Recently closed $20MM Series B strategic financing from an established medical device company. Recent hires include two proven medical device professionals from a well-known local medical device incubator, adding deep experience in implantables, clinical execution, and regulatory strategy. The team is now focused on growing the team to support ongoing development, V&V testing, and progressing toward a First-in-Human clinical study.
The Role
We’re seeking a hands‑on Quality & Design Assurance Lead to own our QMS and Design Quality. The position may be filled by a Quality Manager or a seasoned contributor (Staff or Principal QE) stepping into a true leadership role at a startup while remaining deeply involved in execution.
What You’ll Own
- End‑to‑end ownership of an ISO 13485 / 21 CFR 820 QMS
- Internal and external audits, CAPA, NCRs, Supplier Quality, and documentation
- Design Controls, Design Verification & Validation, Risk Management (ISO 14971), and FMEAs
- Design Quality for implantable electronics, sensors, Nitinol implants, and catheter delivery systems
- Quality oversight for sterilization, biocompatibility, packaging, and labeling
- Inspection readiness for FDA and strategic partner audits
What We’re Looking For
- 8–12+ years of Quality experience in medical devices
- Experience with Class III, PMA, AIMD, implantables, and/or catheter‑based systems
- Strong hands‑on ownership of both QMS and Design Quality
- Comfortable working in a small, fast‑moving startup environment
- Motivated to grow into a broader leadership role as the company scales
Why Join
- Own Quality for a Class III Active Implantable cardiac system
- Strong financial backing, long runway, and experienced senior leadership
- High visibility, autonomy, and real impact on a first‑in‑class technology
Benefits
- Medical insurance
- 401(k)
- Vision insurance
Other Information
No H1B or Visa Transfers — must have US Work Authorization or be a US Citizen.
Local Candidates strongly preferred.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Engineering and Quality Assurance
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