Principal Temporary Works Design Engineer

3 weeks ago

Cardiff, United Kingdom Frontier Medical Group Full time

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. 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.
Principal Design Engineer
Location: Office based in Cardiff (Medicentre, Heath Park, CF14 4UJ)
Hours of work: Monday to Friday 09.Potential for line management responsibilities for Engineer or Junior Engineer
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. 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 in Class 2A/B (is preferred) medical device especially in electro-mechanical systems development. Some project management experience and knowledge on project management methodology.
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
A “finisher” and drive to complete projects, with a track record of products from start to launch
Emotional intelligence and creativity
Committed to professionalism and continuous improvement and personal development

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