Technical Project Scientist, Medical Devices
Salary: Competitive, plus additional company benefits
Our Client, a Global Medical Devices company is expanding and looking to employ an experienced Project Scientist to work cross functionally across the laboratory and across the other key divisions too (internally and externally). Reporting to the Operations Manager, the successful candidate will work on some key projects and play a vital role in the completion of these.
- Supporting the Technical Team strategy in identifying cost savings and product improvements to the existing products ensuring compliance with medical device/FDA procedures.
- Advising on the structure/s and chemical properties of materials, (working alongside Technical Service team members); in identifying suitable test methods and protocols to support recommendations in product improvements for the product range.
- To identify and quantify the effect of changes in component materials within the wound care range.
- Create and carry out test protocols to confirm the validity of alternative materials in the existing product range.
- Running trials and assess findings.
- Preparing protocols, analysing data & preparing reports to support the decision making process.
- Liaising with suppliers; discussing new potential materials and suitability/ improvement of the QMS.
- To develop and validate test methods supporting new product developments with team members.
- To oversee manufacturing trials of new materials with the Process Engineer.
- To form strong relationships with other departments, like R&D to ensure design documentation is updated as per project requirements.
- To form strong relationships with external outsource companies, suppliers and test houses.
- To ensure Health & Safety standards are maintained in the laboratory.
- The jobholder will be required to take decisions on defining project critical path.
- Compliance with relevant GMP, ISO13485 GLP, Health & Safety standards.
- Decisions on time-scale of activities and tasks feasibility of process and product development.
- Jobholder is responsible for ensuring all protocols are written, approved and communicated to relevant groups.
- Jobholder is responsible for training staff on test methods, standard operating procedures, as required etc.
- The jobholder will be involved with managing project teams (internal and external) as part of this position.
- A degree or equivalent qualification in life science or engineering field.
- Project Management experience.
- Experience working within the medical device.
- Knowledge of Woundcare Products and Medical Device Technologies.
- Knowledge of GMP, ISO9001 and Medical Device Directive.
- Knowledge of statistical analysis preferred.
- Experience working with Design Control processes.
- Experience of managing direct reports preferred.
- Good Communication Skills (verbal & written).
- Preparing test methodologies for new materials.