Principal Device Development Engineer - new job in Hertfordshire, UK

Principal Device Development Engineer
  • £55,000 - £65,000 per Annum
  • Permanent
  • Hertfordshire, England, UK SG12 0DP Hertfordshire UK SG12 0DP
Job Ref: BBBH127859
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 26 May 2023
Principal Device Development Engineer - Medical Device

In this role you will...

  • Lead multiple device development work streams for R&D combination product development projects.
  • Take ownership of device work packages, co-ordinating testing activities (e.g. verification, validation, Design of Experiments, robustness studies) to ensure device safety and performance.
  • Responsible for managing platform Design History File (DHF) documentation.
  • Author device development documentation including Design History Files (DHF) and Risk Management Files (RMF).
  • Use problem solving skills and utilisation of different strategies to support resolution of design, manufacturing and regulatory challenges.
  • Collaborate with multi-disciplinary teams across the Company and international sub-contractors.
  • Participate in device risk assessments (e.g. user, design or process risk assessments).
  • Participate in design reviews at critical stages of device development.
  • Work closely with the manufacturing organisation to ensure that methods and processes are transferred for clinical and commercial production.
  • Contribute towards continuous improvement activities to drive quality, efficiency and consistency.

Basic Qualifications

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.
  • Working experience of managing multiple of projects of varying complexity simultaneously.
  • Proven ability to quickly establish relationships with internal and external stakeholders.
  • Understanding and 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.

Preferred Qualifications/ Experience

If you have the following characteristics, it would be a plus:

  • Drive to deliver results and continually improve.
  • People orientated with strong communication and presentation skills.
  • Experience in the regulatory pathways for combination products.
  • Experience with global submissions, agency interactions and authoring dossiers.
  • Experience of human factors / usability engineering (IEC 62366).
  • Excellent written and verbal communication skills.
  • Strong time management / organisational skills.
  • Evidence of team working skills and flexibility.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

25/06/2023 13:38:14
GBP 55000 65000 Annum
Contact Consultant:
Laith Mustafa

Submitting application, please wait..

Share location?

Do you want to share your location for better user experience ?