Role Overview
This position is a Senior Engineer maternity cover, serving as the most senior technical contributor on the project team. The role will lead design quality and project coordination, acting as the primary liaison between R&D, Quality, and Compliance to ensure project deliverables remain on track and meet regulatory and design requirements.
The project involves an iteration of an existing catheter-based medical device that is progressing into clinical trials, with the objective of transferring a commercial-ready version by the end of the year. The successful candidate will be embedded throughout the entire design and transfer process.
An overlap period is required, as the incumbent is expected to leave in May 2026.
Key Responsibilities
* Act as the design quality lead, coordinating across R&D, Quality, and Compliance teams
* Own and drive quality deliverables throughout the design and transfer phases
* Review and approve project documentation in line with regulatory and design control requirements
* Provide day-to-day support to R&D and Compliance on regulatory processes and standards
* Manage the project jointly with an internal permanent team member who will provide support
* Serve as the core point of contact for the project team, ensuring timelines and deliverables are met
Candidate Profile
* Senior-level engineer (benchmark profile similar to Brendan Dunne)
* Minimum 3–5 years' design experience, with proven exposure to end-to-end design control processes
* Strong understanding of design codes, quality systems, and regulatory requirements
* Experience in catheter or catheter-based devices is highly desirable
* Background in Design Quality, R&D, or a hybrid role is acceptable
* Excellent communication and stakeholder management skills; a strong people person who can coordinate effectively across departments
Onsite Requirement:
* Minimum 3 days onsite / 2 days remote
* 5 days onsite during active testing phases