Medical Device Technologist - Hertfordshire
CK Group is recruiting for a Medical Device Technologist to join a company in the pharmaceutical industry at their site based in Ware on a contract basis for 12 months.
The Company: Our client is a global healthcare company who take on some of the world's biggest healthcare challenges. They provide health benefits to patients and consumers and have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
The Location: This role is located on a state of the art R&D facility based in Ware, Hertfordshire. The town lies on the north-south A10 road which is partly shared with the east-west A414 (for Hertford to the west and Harlow to the east). Trains run from London Liverpool Street to Ware and take approximately 45 minutes.
You will be joining this Device Engineering team who are an in-house design and development group charged with the development of drug delivery platforms to support the effective delivery of novel pharmaceuticals. The group comprises a multi-disciplinary group of skills - Industrial Design, Computer Aided Engineering, Computer Aided Design, Mechanical Engineering, Assembly Design, Packaging Design etc. - who develop novel concepts to establish clinical manufacturing/assembly capability with the objective of establishing a design suitable for high volume commercial supply.
- Manage the interface between the design team and the Project Team.
- Manage the development and population of the Design History File in support of any new programme.
- Responsible for the compilation of all regulatory files.
- Responsible for management of governance reviews boards in support of the project team.
- Accountable for the execution of patient handling studies, design verification, design validation and QbD protocols for each project.
Establishment of manufacturing and quality control systems at external suppliers.Your Background:
You will be a graduate in Mechanical Engineering, Biomedical Engineering or related degree.
- You will have experience of the development, manufacture, testing, and quality control of medical devices/combination products.
- Experience in the regulatory pathways for combination products is essential.
- You must be able to demonstrate your ability to manage projects and small internal and external teams. Additionally you need to be able to demonstrate problem solving skills and utilisation of different strategies to support resolution of design, manufacturing and regulatory challenges.
- You must demonstrate your ability to effectively communicate the development programmes to the wider development team and stakeholders.
- Proven track record in product and process development and validation.
- Experience with global submissions, agency interactions and authoring dossiers.
- Comprehensive understanding of design controls, including 21CFR 820.30, risk management processes (ISO 14971), QMS (ISO 13485), relevant human factors and usability guidance, EU MDR, etc.
For more information or to apply for this position, please contact Julie on 01438 723500 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45833 in all correspondence.