A leading medical device company has an exciting opportunity for a Senior Scientist to join its Product Development team. You will be supporting on the new product development of a medical device product in the area of interventional medicine. To be considered, you will have proven commercial experience in the synthesis of new materials and polymers. A PhD in materials or biomaterials would be preferred but equivalent experience will also be considered. A background in Medical Device development is highly desirable but experience gained within another highly regulated industry will also be considered.
Lead technical activities for business unit projects and provide guidance and direction to the technical team. Focus on optimisation of newly designed products within the Business Unit pipeline and ensuring a good technical transfer into manufacturing.
- Primary focus on design and development of medical devices and combination products following the design control requirements 21 CFR 820.30 and ISO13485.
- Lead technical aspects related to the development of new products within the R&D Pipeline for all projects assigned to the technical lead.
- Act as technical authority offering expert guidance and direction on multi-disciplinary product development projects.
- Laboratory based position with minimum of 80% of time spent in the laboratory, planning and running studies in conjunction with members of the technical team.
- Provision of numerical/statistical data to drive design and process development/justify technical findings.
- Management and development of a small technical team, including scientists/engineers, technicians and students.
- Use six sigma tools to ensure that processes and products are developed to the correct standards.
- Working with a manufacturing counterpart, lead new product design transfer activities acting as the sending unit.
- Provision of technical data/packages to support marketing activities for new and existing products.
- Provide regular communication to key stakeholders to ensure visibility of project progress is maintained.
- Carry out other reasonable tasks as required by the Line Manager.
Education and Experience
- Educated to Degree level or above in Materials/Biomaterials Science.
- Medical device and/or pharmaceutical industry experience.
- Skilled in Materials and Chemistry or Engineering.
- Experimental design and DOE skillset.
- Experience of Product Development in the Medical Device industry (other highly regulated and quality driven industries may be considered e.g. Pharmaceutical Industry).
- Lean Six Sigma Green Belt Accredited
- Knowledge of cGMP, ISO13485, Usability standards ISO62636, 21CFR 820 and other relevant regulatory requirements.
- Project management experience/qualification would be advantageous.
- Demonstrated experience in delivering new processes/products into manufacturing, through development to commercialisation.
- Experience or knowledge of biodegradable polymers
Skills and Attributes
- A dynamic and ambitious professional with proven delivery record.
- Strong team player able to demonstrate ability to lead and facilitate informal and formal teams in the development and delivery of quality solutions.
- Able to work across a matrixed organisational environment.
- Must be able to work under pressure and co-ordinate multiple activities concurrently.
- Hands on approach, problem solving mind set, good attention to detail, organised and methodical.
- Demonstrated ability to extract critical information to enable effective and appropriate decision making.
Competitive Salary and benefits
Job Ref: 5817