Job title – Senior Medical Device Development Engineer
Location – Ware, Hertfordshire / Remote working
Rate – PAYE £42 / Umbrella £53 per hour
Start date – ASAP
Contract – 12 Months
Our client is currently seeking an experienced Senior Medical Device Development Engineer to join their team in Ware, Hertfordshire/remote working, this contract will be for 12 months with a review to be extended.
In this role you will
- Use problem solving skills and utilisation of different strategies to support resolution of design, manufacturing and regulatory challenges.
- Support device development work streams for R&D combination product development projects.
- Work across platform devices, co-ordinating development activities and managing platform documentation.
- Collaborate with multi-disciplinary teams and international sub-contractors.
- Facilitate risk assessments (e.g. user, design or process risk assessments)
- Participate in design reviews at critical stages of device development.
- Participate in device development project team meetings, ensuring development deliverables are met.
- Compile device development documentation including Design History Files and Risk Management Files.
- Co-ordinate testing activities (e.g. verification, validation, Design of Experiments, robustness studies) to ensure device safety and performance.
- Work closely with the manufacturing organisation to ensure that methods and processes are transferred successfully for commercial production.
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- 1st or 2:1 in Mechanical Engineering, Biomedical Engineering or related degree.
- Experience of medical device or combination product development.
- Experience of working within device regulatory requirements and industry processes such as design controls (21 CFR 820.30), EU MDR 2017/745, risk management (ISO 14971), QMS (ISO 13485) and GMP.
- Ability to quickly establish relationships with internal and external stakeholders.
- Strong communication skills.
- Thrives in fast paced environments.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Experience in the regulatory pathways for combination products.
- Experience with global submissions, agency interactions and authoring dossiers.
- Excellent written and verbal communication skills
- Strong time management/organisational skills
- Evidence of team working skills and flexibility
If you are relevant or interested please don’t delay, contact me on /
Employment Type Contract
Advertiser Type Agency