Test Lead

7 days ago

Stockholm, Stockholm, Sweden Capgemini Full time

We are currently looking for a Functional Test Lead to join our Compliance, Quality and Regulatory team (CQR) for an exciting assignment within medical device development. The primary role of this position is to be responsible for timely planning and proper execution of test engineering in medical device development projects, based on identified and agreed needs to fulfill objectives at the project level.

Responsibilities include:

  1. Act as Functional Test Lead on device projects
  2. Execute Test Engineering Work Packages
  3. Plan, execute, review and report on testing
  4. Drive strategic improvement opportunities, establish best practices, and share knowledge
  5. Act as process or subject matter expert
  6. Act as strategic test partner to client's device project teams

Main job tasks

As Functional Test Lead at Capgemini Engineering, you will:

  1. Act as functional test lead on device projects and represent Test Engineering and Test Execution teams in projects throughout the development process
  2. Coordinate all deliverables with functional method validation leads and lab technicians and be accountable for project investigations
  3. Execute test engineering packages and participate, contribute and provide input to specifications, project plans, protocols, and reports
  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

Your profile

We believe that you have a degree in Mechanical/Biomedical Engineering or a related engineering discipline, with 2-5 years of experience in test engineering within medical device development, including the following aspects:

  1. Tests and measurements
  2. Verification of requirements
  3. Data analysis & statistics
  4. Test standards and regulations
  5. Requirements engineering
  6. Medical device design control
  7. Project management
  8. Navigating a GMP-regulated environment
  9. cLEAN
  10. Business understanding and end-to-end mindset
  11. Establishing and enabling strategy
  12. Defining and driving process improvements or digitalization

You have a very good understanding of medical device regulations and standards, such as 21CFR820, ISO13485, and ISO17025, and a proven track record of successfully managing testing within medical device development projects. You are skilled in communication and possess strong leadership abilities, with the capacity to effectively collaborate with cross-functional teams, stakeholders, and external partners.

You are:

  1. Fluent in written and spoken English
  2. On an advanced level of coordination and communication
  3. Proactively acting and able to work independently
  4. Curious and motivated by exciting challenges
  5. A person who takes initiative, is flexible, and thrives in a dynamic environment
  6. A person who finds it easy to cooperate and communicate with different groups of people
  7. Genuinely interested in technology and problem solving
  8. A strong team player
  9. Driven by challenges and personal development

When you join Capgemini, you don't just start a new job. You become part of something bigger.

#J-18808-Ljbffr

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