Design Verification and Validation Engineer

Design Verification and Validation Engineer

Location: Cardiff

Job type: Full time, permanent

Shift pattern: Monday to Friday, 37 hours per week

Job closes: 31/12/:00 am

Responsibilities

• Develop, execute, and report verification activities for assigned projects.
• Involve throughout the full project lifecycle from design to product release.
• Work within the R&D team to perform concept and product development testing to confirm performance against specifications.
• Keep abreast of current state of the art, industry standards, competitors, and market trends.
• Collaborate with manufacturing and service teams to develop and implement tests for continued product conformance.
• Participate in usability testing and documentation to meet EN60601-1-16 / IEC62366.
• Create and execute comprehensive design verification test plans and protocols.
• Design and implement reliability test plans, including gauge repeatability and reproducibility (GR&R) studies when required.
• Analyse verification and reliability data to assess conformance with acceptance criteria.
• Prepare formal reports and summary results for testing.
• Assist the engineering team with root cause analysis for issues identified during V&V testing.
• Work with lab technicians to assemble, test, and troubleshoot mechanical, electronic, electromechanical, and pneumatic test setups and data acquisition systems.
• Develop custom control, user interface, and data collection programs using LabView.
• Perform all activities in accordance with company QA procedures and regulatory regimes such as MDR (EU), ISO13485, FDA CFR 820, and IEC60601.
• Coordinate with other departments and sites to ensure seamless transition of new products from design to manufacture/test.
• Execute risk management activities, documenting risk control measures.
• Maintain calibration and maintenance records for new equipment.

Qualifications

• Degree level (or equivalent) in engineering or related field.
• Minimum 2 years of experience in a commercial product design environment.
• Knowledge of risk management (ISO14971), safety (IEC60601), and usability principles.
• Strong team player with excellent verbal and written communication skills across disciplines.
• Ability to prioritize between multiple projects and assignments.
• Capacity to identify benefits and synergies within interdisciplinary and cross cultural teams.
• Self directed planning and organizational abilities.
• Drive for personal development and self leadership with an improvement mindset.
• Lead and facilitate team activities.
• Skilled in modern product development best practices and applicable tools.
• Experience in regulated industry environments.
• Willingness to travel domestically and internationally as required.

Additional Information

Support our vision of collective excellence in healthcare. We value our global employees and offer full support, training, and opportunities for professional development, along with a competitive package.

At Huntleigh Healthcare, we believe in the power of diversity. We strongly encourage applicants from all backgrounds, fostering an inclusive and engaging environment.

Please be aware that by applying for this role, you are giving Huntleigh permission to store your information.

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Huntleigh's product range gives you a variety of ways to address your clinical challenges. If you're not sure, our team is always available to answer any queries and ensure you get the perfect solution for you.