Design History Project Manager/Coordinator
Design History Coordinator- Medical Device
Contract: Full-time, permanent
Location: Oxford (hybrid working)
Salary: Up to £50,000 per annum- flexible
Osler has the potential to transform global health. It has built the foundation to do so and demonstrated that the vision can be realised. You will help realise this opportunity, shaping the direction of a rapidly scaling company, operating in a high-pace, visionary, intellectually rigorous, and (crucially) pragmatic environment, where you will be expected to be proactive, engage in debate, think strategically, and contribute towards our purpose to improve the lives of hundreds of millions of people.
As part of the Delivery Practice, the Design History Coordinator will own the collation and management of Osler’s design and development records, working across the product development team to ensure that new product development is documented and recorded.
This role will drive best practice for creation and maintenance of design history, supporting development traceability and delivery of material for worldwide regulatory submissions. You will generate high quality documentation, and support others to do the same, through hands on guidance and mentorship.
You will bridge R&D, QARA, Production and Product Management functions to identify what should be recorded, when and how. You will use your experience of regulated product development to establish pragmatic documentation practices supporting fast paced product development within an ISO 13485 QMS.
- Work cross-functionally with our technical, QARA, production and commercial teams to ensure design history for product development is properly documented and maintained
- Support and mentor technical teams in generation of design documents and records required for compliant design history and regulatory technical files
- Coordinate and document design meetings and formal design and development phase reviews, making sure phase deliverables are prepared and reviewed
- Assist the technical team in the application of requirements for regulated medical device product development, helping them to interpret what should be recorded, when and how
- Manage Osler’s electronic design history files, ensuring these are maintained and controlled, ready to support regulatory submissions
- Maintain processes and systems to manage product requirements, risk management, design outputs and their verification and validation to ensure traceability through development
- Identify and implement the best ways to balance compliant design documentation with fast paced delivery, using and championing ways of working that allow Osler to maintain speed to market as a key differentiator in the medical device field
- Identify and help to resolve or escalate delivery related tensions or delays
- Facilitate collaborative working, helping multidisciplinary teams to understand what is needed in terms of design history, and being proactive in resolving blockers and challenges
Current skills/knowledge must include:
- Experience in product development environment and / or diagnostics / biotech / engineering
- Experience of working within the medical device and/or IVD industry
- Experience in new product development design process and generation of design records and documentation to support regulatory submissions
- Project coordination and facilitation across functional technical teams
- Excellent written and spoken English, confident communication with all types of stakeholders
- Experience of working within a QMS
- Highly competent in Word, Excel, PowerPoint etc
OSLER WINNING BEHAVIOURS
Courage Stepping up to address difficult issues, saying what needs to be said
Instills Trust Gaining the confidence and trust of others through honesty, integrity and authenticity
Nimble Learning Actively learning through experimentation when tackling new problems, using both successes and failures as learning fodder
Collaborates Building partnerships and working collaboratively with others to meet shared objectives
Action Orientated Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
Self Development Actively seeking new ways to grow and be challenged using both formal and informal development channels.
There is no perfect candidate and no single person can do it all, but if this sounds like you, or what you could be and you're looking for somewhere to thrive; we want to hear from you.
This is a rare opportunity to be at the cutting edge of new product development in a truly multidisciplinary environment where you can see the power and impact of your work on the end product. In order to create, not only something new, but a step-change in what we think is possible, we expect the best people, to do their best. This is a special place where we encourage everyone to be entirely themselves in order to be your best self.
We look forward to receiving your application. If you have any questions, please contact email@example.com
Join us and build a better future.