Science & Technology

Senior Medical Device Development Engineer

Not Specified

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