Overview
Job Purpose: Design verification and Validation engineer for assigned projects providing the development, execution, and reporting of verification activities.
Functions: 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.
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.
* To 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 in order 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.
Knowledge/Experience
* Experience from work in regulated industry.
Personal Qualities
* Passion for the healthcare industry.
* Qualified up to degree level (or equivalent) in engineering.
* Ideally 2 or more years experience in a commercial product design environment.
* Applies the principles of risk management (ISO14971), safety (IEC60601) and usability.
* Good team player and able 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.
* Ability and initiative to drive own personal development and self-leadership with an improvement mindset.
* Ability to lead and facilitate team activities.
* Skilled in modern product development best practice and applicable tools.
* Experience from work in regulated industry.
* Ability to approach tasks and problems with a structured and outcome-oriented mindset.
Special Features/Conditions
* The role may require domestic and international travel
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.
For more information about Arjo visit www.arjo.com
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