iSMART Developments
Design Quality Engineer
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Job Title: Design Quality Engineer
Location: Remote, UK-based, with attendance in person at design reviews, programme gates and partner sites
Department: Design & Development, within New Product Development
Works With: Internal engineering and industrial design, Regulatory, Supplier Quality and the engineering teams at our manufacturing partners
Travel: UK and international, as programmes require
Position Type: Full-Time
About Us
iSMART develops and manufactures advanced LED phototherapy devices for the world's leading beauty, dermatology and medical brands. We hold an FDA clearance on a five-wavelength light protocol, an international patent estate in stretchable printed electronics, and partnerships including L'Oréal Groupe. Our engineering, industrial design and intellectual property are held in-house, and we work alongside the engineering teams at our manufacturing partners to take products from concept to global launch across skincare, longevity, wellness and healthcare.
Our Advantage
- Regulatory Leadership: MDSAP ISO 13485 certified, FDA & MDR approvals across global markets
- Clinical Heritage: Devices validated through independent studies & peer-reviewed studies
- Proven Science: Optimised wavelengths with robust efficacy data
- Medical Applications: Acne, wrinkles, pigmentation, pain, wound healing, dermatitis & ongoing trials
- Manufacturing Excellence: We partner with MDSAP-regulated manufacturers, ensuring every device meets the highest global standards of safety, quality, and compliance.
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Why this Role Exists
We are increasing the number of development programmes we run in parallel. We are not looking for someone to check work after it is finished. We are looking for an engineer who joins programmes at concept, shapes the risk and verification thinking alongside the design team, defines what must be true about the product for it to be safe and effective, and leaves the way we work simpler than they found it.
Key Responsibilities
- Drive Design Controls: Partner with internal & external R&D teams to navigate the full product lifecycle, ensuring absolute compliance with ISO 13485 and MDSAP.
- Lead Risk Management: Facilitate and maintain product risk management files using ISO 14971 frameworks, including dFMEAs and pFMEAs.
- Oversee V&V Activities: Review and approve master test plans, protocols, traceability matrices, and technical reports for regulatory submissions (FDA 510k / EU MDR).
- Bridge Design to Manufacturing: Support Design for Manufacturability (DFM) and collaborate with supplier quality teams on component qualification and inspection plans.
- Champion Compliance: Lead root-cause investigations, manage CAPAs, and serve as a technical subject matter expert during FDA and Notified Body audits.
Requirements
- Education: Bachelor’s degree in Electronic or Mechanical Engineering.
- Experience: 5+ years of quality engineering experience in the electronic medical device or combination products industry.
- Regulatory Expertise: Robust, hands-on knowledge of EU MDR, ISO 13485, MDSAP and ISO 14971.
- Technical Skills: Strong proficiency in statistical analysis, Minitab, Gauge R&R, and root-cause analysis methodologies.
- Certifications (Preferred): ASQ Certified Quality Engineer (CQE).
- Willingness to travel overseas and in the UK to supplier sites as needed.
- Excellent analytical, communication, and problem-solving skills.
- Project Management – ability to manage the projects and ensure on time delivery.
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Preferred Skills
- Clearly communicate project status, quality risks, dependencies and mitigation plans to project teams and senior management.
- Develop strong working relationships with internal departments, external suppliers and customer stakeholders.
- Strong commercial acumen, able to balance business objectives with quality and regulatory requirements while supporting successful project delivery.
- Excellent project management and organisational skills with the ability to manage multiple priorities simultaneously.
What We Offer
- Competitive salary and performance-based bonuses.
- Opportunities for professional development and continuous learning.
- Workplace pension and life assurance.
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