Device Performance Lead
3 days ago
We are seeking an experienced professional to join our team as a Device Performance Specialist.
About the Role:This is an exciting opportunity to work in a dynamic environment where you will be responsible for providing subject matter expertise to support the development of combination products.
Key responsibilities include leading a team to plan and execute design verification and reliability strategies, responsible for technical interface between drug product and device teams during combination product development, and responsible for developing test methods and specifications to assess device functionality and product performance.
The ideal candidate will have a degree in science/engineering (Master's preferred) and proven experience in pharmaceutical and/or medical device development.
Requirements:- Degree in Science/Engineering (Master's preferred)
- Proven experience in pharmaceutical and/or medical device development
- Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage
- Experience in the development and validation of analytical methods
- Experienced in application of statistical techniques for data analysis
- Experience of writing and supporting regulatory submissions
- Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role.
We offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Sustainability:Corporate social responsibility is fundamental to our mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve.
Viatris empowers people worldwide to live healthier at every stage of life. By integrating the strengths of two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance.
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