Functional Test Strategy Specialist

23 hours ago


Stockholm, Stockholm, Sweden Capgemini Full time

Capgemini is seeking a highly skilled Functional Test Strategy Specialist to join our Compliance, Quality and Regulatory team (CQR). As a key member of our team, you will be responsible for developing and implementing test strategies for medical device development projects.

Key Responsibilities

  1. Develop and implement test strategies to ensure the quality of medical devices
  2. Execute test engineering work packages and participate in the development of specifications, project plans, protocols, and reports
  3. Collaborate with cross-functional teams, stakeholders, and external partners to ensure effective project delivery
  4. Identify and drive improvement opportunities, complex solving, and create new guidance
  5. Ensure training for the test team in expertise areas
  6. Lead and facilitate strategic test-related project decisions

Requirements

For this role, we are looking for someone with a degree in Mechanical/Biomedical Engineering or a related engineering discipline, with 2-5 years of experience in test engineering within medical device development. You should have a good understanding of medical device regulations and standards, such as 21CFR820, ISO13485, and ISO17025.

Additionally, you should possess strong leadership abilities, with the capacity to effectively collaborate with cross-functional teams, stakeholders, and external partners. You should be fluent in written and spoken English, have advanced coordination and communication skills, and be proactive in acting and working independently.



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