Job Description:
We are seeking a highly skilled professional to join our team as a Device Performance Specialist. This individual will be responsible for developing and validating analytical methods, providing technical expertise to support the development of combination products, and ensuring that these products meet reliability requirements.
The successful candidate will have experience in pharmaceutical and/or medical device development, with a strong background in statistical techniques and data analysis. They will also possess excellent communication skills, with the ability to write and support regulatory submissions.
In this role, you will work closely with cross-functional teams to support innovative technology solutions and provide healthcare solutions for our patients. You will be responsible for activities such as metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport & shipping studies, and testing of combination products within the Global Device Development portfolio.
Trend and statistical analysis of analytical data will be an essential part of your responsibilities, including compilation of technical reports to support combination product development lifecycle. You will also be required to ensure that the Combination Product meets any requirements for reliability, through implementation of appropriate controls and assessment of the product against suitable specifications.
Requirements:
* Bachelor's or Master's degree in Science/Engineering
* Proven experience in pharmaceutical and/or medical device development
* Experience in the development and validation of analytical methods
* Experienced in application of statistical techniques for data analysis
* Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage
* Experience of writing and supporting regulatory submissions would be an advantage