Principal Device Development Engineer - new job in Hertfordshire, UK
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.
Contact Consultant:
Laith Mustafa
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