Senior Design Quality Engineer

Medical Devices | New Product Development | Design Assurance | Risk Management

Are you passionate about bringing innovative medical technologies to market while ensuring the highest standards of quality, safety and compliance?

An established and growing medical device organisation is seeking a Senior Design Quality Engineer to play a key role in the development of cutting-edge products spanning sterile disposables, software-driven systems and electromechanical medical devices. This is an exciting opportunity to partner with cross-functional teams and influence product quality from early concept through to commercial launch.

As a Senior Design Quality Engineer, you will provide leadership and expertise across Design Controls, Risk Management and New Product Development activities, ensuring products are developed in accordance with global regulatory and quality requirements.

Working closely with R&D, Regulatory Affairs, Manufacturing, Operations and Commercial teams, you will help drive quality-by-design principles and support the successful introduction of new medical technologies to patients worldwide.

• Lead Design Assurance activities throughout the product lifecycle, from concept through commercialisation.
• Ensure compliance with Design Controls, Risk Management and Quality System requirements.
• Facilitate and lead risk management activities including Hazard Analysis, FMEA and risk assessments.
• Partner with cross-functional project teams to embed quality-by-design principles into product development.
• Support Design Verification and Validation (V&V) strategies and execution.
• Drive successful design transfer activities into manufacturing environments.
• Provide quality oversight for software and connected medical device development, ensuring compliance with IEC 62304 and applicable FDA guidance.
• Support product cybersecurity initiatives, threat assessments and cybersecurity risk management activities.
• Act as a subject matter expert on quality engineering tools, statistical analysis, root cause investigations and risk assessment methodologies.
• Contribute to post-market surveillance, product investigations and continuous improvement initiatives.
  
  

• Bachelor's degree in Engineering, Biomedical Engineering or a related scientific discipline.
• 5 years of Design Quality, Design Assurance or Quality Engineering experience within the medical device industry.
• Strong experience supporting New Product Development and product launches.
• Working knowledge of:
  • FDA 21 CFR Part 820 / QMSR
  • ISO 13485
  • ISO 14971
  • IEC 62304
  • IEC 60601
  • ISO 10993
• Experience with Design Controls, Risk Management and regulatory documentation.
• Hands-on knowledge of quality engineering tools including FMEA, URRA, SPC, RCA, MSA and Gage R&R.
• Experience supporting process validation and equipment qualification activities (IQ/OQ/PQ).
• Strong communication skills with the ability to influence stakeholders across multiple functions.
• Self-motivated, highly organised and comfortable operating in a fast-paced development environment.