Project Manager - Medical Device
Biotechnology Life Sciences
Project Manager – Medical Devices
An exciting opportunity has come up for an experienced project manager to join a medical device start up at their site in Southampton. Combining technical and clinical expertise to develop advanced, miniaturised biometric sensors, our client produce implantable and wearable devices that use wireless, battery-less technology capable of capturing and analysing biometric data.
The project manager (medical device) will support the Lead PM responsible for executing, managing and monitoring key elements of the project from initial project planning through to product launch. The Project Manager will organise cross-functional activities, ensuring completion of specific elements on the schedule, within budget and meeting all technical requirements, including completing submissions for MHRA clinical study.
Some other main responsibilities include:
- Manage project plans, schedules and deliverables
- Maintain project schedule by monitoring project progress, coordinating activities, resolving issues and proactively managing risks
- Design Control through a gated development process and associated decision-making
- Manage and motivates cross functional project team, facilitates the teams’ ability to achieve project objectives
- Maintain effective communication with all parts of the organisation, across functions and with line management, in all activities required to design, develop and deliver the product successfully
- Write and implements comprehensive verification and validation plans
- Assist in the development and maintenance of product/project documentation required by Engineering SOP’s and national/international quality standards and regulations;
- Create and maintains medical device Design History Files and Device Master Records. Manages and conducts medical device testing and maintains product records with compliance to ISO 13485 and internal SOP’s.
- Assist with management of suppliers, vendors, and ongoing subcontractor relationships using knowledge of regulatory requirements applying to manufacturers’ processes and products.
Ideally candidates will be qualified to degree level (or equivalent) in technical/engineering discipline (biomedical, electronic, mechanical, materials), or a related subject. The successful project manager will possess in-depth experience in engineering and manufacturing a medical product; experience in medical product project management and working within a medical device regulated environment and be well organised, able to multi-task and work to tight deadlines under pressure.
As this is a start-up organisation, an ability to be flexible with the ability to be innovative and creative with ideas, have a can-do approach whilst being able to challenge others and open to being challenged is essential.
If this sounds like the opportunity for you, apply now with your CV, and feel free to contact Tom Kirkpatrick at CY Partners for more information.