Principal Design Engineer

Job Description
Are you ready to embark on a transformative journey in the medical device industry? Join us at our Cardiff Innovation Hub as a Principal Design Engineer and become a driving force behind groundbreaking NPD projects. In this role, you'll have the opportunity to lead our dynamic R&D teams, guiding them from concept to product launch with innovative solutions. Your expertise in electro-mechanical systems development for Class 2A/B medical devices will be pivotal as you ensure compliance with industry standards such as ISO13485 and 21CFR820. Beyond technical prowess, you'll play a key role in crafting meticulous documentation for regulatory submissions, supporting quality activities, and spearheading non-conformance and corrective action processes. While we value experience, we're more interested in your passion for problem-solving and your dedication to engineering excellence. If you're ready to make a meaningful impact and shape the future of medical technology, we invite you to join our team and embark on this rewarding journey with us.
At this time, we kindly request that agencies refrain from contacting us regarding this opportunity. We are currently managing our recruitment process internally and appreciate your cooperation in respecting our preferences.
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Job Title:
Principal Design Engineer
Location:
Office based in Cardiff (Medicentre, Heath Park, CF14 4UJ)
Hours of work:
Monday to Friday 09.00-17.00
Responsible to:
R&D Manager
Responsible for:
Potential for line management responsibilities for Engineer or Junior Engineer
Main purpose of job:
To provide technical leadership to R&D teams to deliver NPD project from discovery to product launch, preparing the technical file and design history file for regulatory submission. It will include support regulatory affairs and quality activities to ensure products meet regulations. Lead and support NCR and CAPA.
Qualifications required:
Master’s degree (MSc) post-graduate degree in Mechanical/Biomedical/ Medical/Materials Engineering is preferred. Alternative is MEng degree or BEng (1st or 2,1 Hons) in Mech/Biomedical/Medical/Materials Engineering
Experience required:
Experience in Class 2A/B (is preferred) medical device especially in electro-mechanical systems development. Familiar with key standards such as ISO13485, IEC60601 and 21CFR820. Knowledge on IEC62304 is desirable. Some project management experience and knowledge on project management methodology.
Essential skills:
Leadership, application of engineering principles and problem solving, innovative and creative, developing solution and can make technical decisions, coaching of team, working with a team
Key personal attributes:
“Can do” attitude; A “finisher” and drive to complete projects, with a track record of products from start to launch
Honesty and integrity
Dependability and reliability
Flexibility and willingness to work collaboratively
Emotional intelligence and creativity
Committed to professionalism and continuous improvement and personal development
Must have a positive & optimistic attitude, very responsive and helpful always
Customer and patient focus – safety and usability
Team player - working as part of a close-knit team
Other desirable skills / experience:
Clinical knowledge and skills (desirable)
Employment checks:
Checks will be carried out on right to work in the UK where appropriate