Verification and Validation engineer

Overview

Design verification and Validation engineer for assigned projects providing the development, execution, and reporting of verification activities. The Verification and Validation engineer works as part of a multi-disciplinary product development team involved in taking projects from concept through to manufacturing and product release. Functions as design verification lead on assigned projects providing the development, execution and reporting of verification activities.

Key Duties and Responsibilities

• Involvement in the full project lifecycle from initial design/development to product transfer to manufacturing and product release.
• Work within the research and development team to enable concept and product development testing confirming performance to required specification.
• Keep abreast of current state of the art and development within relevant industry standards, competitors and market trends.
• Work with manufacturing and service teams to develop tests for use in confirming the continued conformance of products.
• Involvement in Usability testing and documentation to meet EN60601-1-16 / IEC62366.
• Create and execute comprehensive design verification test plans and protocols; develop and execute reliability test plans.
• Execute gauge repeatability and reproducibility (GR&R) studies when needed to assess measurement system effectiveness.
• Analyse data from verification and reliability tests for conformance to pre-determined acceptance criteria.
• Prepare formal reports and results summaries for testing as required.
• Assist engineering team with root cause analysis for problems 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.
• Create custom control, user interface, and data collection programs using LabView.
• Carry out activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and IEC60601.
• To liaise with other departments and sites to ensure a smooth and rapid transition of new products from design to manufacture/test.
• Risk Management activities, ensuring risk control measures are recorded.
• Responsible for registering new equipment, calibration and maintenance records.
• Qualifications include a degree in engineering (or equivalent); ideally 2 or more years of experience in a commercial product design environment.
• Applies the principles of risk management (ISO14971), safety (IEC60601) and usability.
• Good team player with ability to communicate at many levels and across disciplines in verbal and written form.
• Ability to work with and prioritise between multiple projects and assignments.
• Ability to find benefits and synergies within interdisciplinary and cross-cultural team collaborations.
• Ability to plan and organize work autonomously and demonstrate initiative for personal development and self-leadership.
• Ability to lead and facilitate team activities.
• Skilled in modern product development practices and applicable tools.
• Experience in a regulated industry.

About Arjo

At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges.