Design Verification and Validation Engineer

Design verification and Validation engineer for assigned projects providing the development, execution, and reporting of verification activities

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.

Any other duties as required enabling the organisational objectives to be met.

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 standards.

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.

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 useability.

Good team player and able to communicate at many levels and across disciplines in verbal and written form.

Ability to work with and priortize between multiple project 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.

Knowledge/Skills/Experience:

The role may require domestic and international travel

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 parts of society, which means building a more diverse, equitable, inclusive and engaging environment – not only in the workplace, but also within the communities that we serve, work in and live in. We achieve this through a culture and mindset that values the uniqueness of all our people.

To us it matters not only what we do, but also how we do it. There are four components of our culture: 

Diversity & Inclusion – we view diversity as a driver of innovation & a catalyst for our global growth

Winning as a team – where members of our team are empowered to make decisions at the right level

Leadership style – being visible, connecting with others and leading by example

Our core values – Passion, Collaboration, Openness, Ownership & Excellence

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

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

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