Seeking a seasoned project leader to drive medical device development and manufacturing initiatives.
This is an exciting opportunity to contribute to the full product development lifecycle, from concept through to commercial scale-up. The role offers a dynamic environment with a focus on employee wellness and professional development.
Main Responsibilities:
* Lead the planning, execution, and delivery of new product development projects within the medical device sector.
* Oversee product and process evaluation activities, ensuring alignment with quality and regulatory requirements.
* Coordinate the preparation of documentation for regulatory submissions in line with EU and US standards.
* Review and assess design outputs, driving effective design control and decision-making.
* Serve as the main point of contact for customers, providing updates on project milestones and progress.
* Establish and manage supply chains to support the transition from development to production.
* Coordinate the implementation of necessary tooling, equipment, and capital investments to ensure successful project delivery.
* Collaborate cross-functionally to ensure compliance with ISO 13485 and other relevant regulations.
Requirements:
* Degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
* Minimum of 5 years' experience in engineering design, product development, or a similar role.
* Strong ownership mindset with a track record of delivering projects from concept to completion.
* Proficiency in CAD tools such as SolidWorks, AutoCAD, or similar.
* Excellent communication skills and ability to work independently in a regulated environment.
Benefits:
The company offers a dynamic and growing environment with a strong focus on employee wellness and professional development.