Medical Performance Specialist
4 weeks ago
This Medical Performance Specialist role offers an exciting opportunity to make a significant impact in our Device and Product Performance team at Viatris Inc.
Located in Sandwich, England, UK, this 18-month fixed-term contract is perfect for those seeking a challenging yet rewarding experience.
Responsibilities- Conduct metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport & shipping studies.
- Develop and validate test methods to support Design Verification Testing, either internally or externally.
- Collaborate with Viatris Affiliates and Third-Party Companies to manage exhibit and registration batches, ensuring compliance with controls and additional requirements.
- Responsible for testing combination products within the Global Device Development portfolio, including generating protocols, overseeing execution at external facilities, and writing reports.
- Analyze analytical data, compile technical reports, and ensure combination products meet reliability requirements.
- Compile and review technical documentation within GDD, adhering to global regulatory requirements, guidelines, and industry thinking.
- Support R&D Lab activities, including equipment calibration and qualification, documentation, trackwise records, EHS training, and risk assessments.
- Lead general laboratory activities, such as procedure updates, metric generation, sample management, data review/verification, instrument daily calibrations, and shipping samples.
The ideal candidate will possess a degree in Science/Engineering (Master's preferred), with 3+ years of experience in pharmaceutical and/or medical device development. Strong statistical analysis skills, experience with regulatory submissions, and a driven, motivated attitude are also essential.
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