Medical Device Development Leader
We are seeking a seasoned development leader to drive the creation of innovative medical devices in interventional cardiology.
You will play a key role in steering the product through clinical and regulatory pathways to market, collaborating with cross-functional teams including engineering, clinical, regulatory, and commercial stakeholders.
This opportunity offers the chance to be part of a dynamic environment, contributing directly to the success of pioneering technology in the cardiovascular space.
* Lead the execution of full product development programs from concept to manufacturing and scale-up in regulated environments.
* Establish and manage robust project plans and timelines; ensure program delivery on time and within budget.
* Implement structured engineering review processes to minimize design risks.
* Coordinate workstream activities and prioritize critical path tasks.
* Communicate clearly with all internal and external stakeholders regarding project progress and risks.
* Anticipate potential issues and develop effective mitigation strategies.
* Oversee program resources and planning.
* Collaborate with functional leaders to support team development and recruitment.
* Contribute to the implementation of quality systems aligned with ISO and regulatory standards.
* Promote innovation and support IP generation to protect novel developments.
Candidate Requirements:
* Master's Degree in Biomedical Engineering or related discipline (or equivalent industry experience).
* Minimum 10 years' experience in medical device development, ideally in cardiovascular or interventional cardiology.
* Proven track record in development leadership within regulated environments.
* Strong organizational and project execution skills with ability to manage multiple priorities.
* Comfortable working autonomously in fast-paced environments.
* Excellent leadership, communication, and interpersonal skills.
* Entrepreneurial mindset with proactive and solution-driven approach.
* Understanding of quality systems and regulatory frameworks.