Principal Device Development Engineer - new job in Hertfordshire, UK

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.