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Medical Device Strategist

3 weeks ago

Dublin, Dublin City, Ireland Plio Surgical Full time

Plio Surgical is a pioneering Medtech company developing a groundbreaking, minimally invasive implant for gastrointestinal surgery. As we prepare for clinical trials and regulatory submissions, we're looking for a highly skilled Chief Technology Officer (CTO) to lead our product development efforts.

The CTO will play a critical role in shaping our product roadmap, ensuring seamless design verification, First-in-Human trials, CE and FDA submissions, and successful commercial launches. They'll build and mentor a talented engineering team, contributing to the executive leadership team and influencing fundraising, commercial planning, and investor relations initiatives.

We're seeking someone with:

  1. A strong background in bringing medical devices from concept to market.
  2. In-depth knowledge of design control, human factors engineering, and risk management, particularly within ISO 13485 and FDA/MDR regulatory contexts.
  3. Previous experience in start-ups or early-stage companies is beneficial but not essential.

Plio Surgical offers a competitive equity package and salary aligned with industry standards.