260 days ago on career012.successfactors.eu

Engineering Test Strategy & Verification Lead

Merck Gruppe

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 Please refer to JobSuchmaschine in your application

Engineering Test Strategy & Verification Lead

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees in 67 countries work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions.


Your role: Be responsible for defining and managing the Test Strategy and device verification activities for projects within the Device Engineering team. In the role, you will be responsible to collaborate with and provide support to medical device projects in preparing, writing and reviewing of internal and supplier V&V test plans, protocols and resulting test reports. This will include responsibility for ensuring the strategy and protocols contain statistically valid sample sizes, robust V&V methodology and coverage and accurate reporting of the output such that it is aligned with Regulatory requirements and Good Documentation Practices (GDP). You have a bias for action and can break down complex problems into steps that drive product development. You have a “begin with the end in mind” mentality who understands what needs to be delivered from the V&V activities to successfully bring a product to launch. As a technical expert in the area of testing, you will play a key role in the delivery of Merck’s medical device solutions.


Who you are

  • A passionate desire to help improve the lives of people living with chronic diseases
  • Degree (or equivalent) in an applicable Mechanical, Materials Science or Electronic/Software Engineering field
  • Experience in leading and executing the V&V of complex medical device development projects, from V&V plan authoring, protocol creation, verification execution, to V&V summary report compilation, and traceability from requirements to verification evidence which meet product development and external governing and regulatory body requirements
  • Profound understanding of requirements management, from aiding with requirements elicitation to ensuring that requirements are testable and verifiable
  • Experience of test automation as a tool to reduce verification timelines
  • Experience in the development of test methods, structures and the qualification and tech-transfer of these to mass production
  • Understanding of project and product risk management and mitigation and how this inputs into an overall product test strategy
  • Expert working knowledge of Quality standards and regulations applicable to design and manufacture of a medical devices including combination product development and process qualification. (Knowledge of verification against ISO 11608 advantageous).  
  • Expert understanding of FMEAs as a risk management tool




What we offer:Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.


Curious? Apply and find more information at come2merck.com