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Senior Device Performance Specialist
2 weeks ago
We are seeking an experienced professional to join our team as a subject matter expert in device and product performance.
The ideal candidate will have a strong background in pharmaceutical and medical device development, with expertise in design control requirements and analytical method validation.
Responsibilities- Provide technical support for combination product development, including formulation and manufacturing activities.
- Lead the development of design requirements and specifications based on characterization of comparator products and regulatory requirements.
- Develop test methods and specifications to assess device functionality and product performance.
- Assess device components for material compatibility and ensure quality standards are met.
- Collaborate with manufacturing sites to develop filling and assembly processes.
- Apply statistical techniques for data analysis to inform design decision making.
- Master's degree in Science or Engineering.
- 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.
- Experience in analytical method validation and statistical techniques for data analysis.
- Ability to communicate technical information effectively.
- Travel may be required.
This is an exciting opportunity to work with a dynamic team and contribute to the development of innovative device technologies.
As a subject matter expert, you will have the opportunity to apply your technical skills and knowledge to drive business results.
Viatris offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
Key Qualifications- Strong technical skills and knowledge in device and product performance.
- Excellent communication and collaboration skills.
- Ability to work independently and as part of a team.
