
Scientist Mechanical Design Specialist
7 days ago
Job Overview
">We are seeking an experienced Principal Scientist to join our team in the development of Combination Products.
The successful candidate will provide subject matter expertise to support the development of Combination Products, including mechanical design and development. They will lead a team to plan and execute design verification and reliability strategies, ensuring formulation and manufacturing development activities are compatible with device development.
The Principal Scientist will be responsible for developing design requirements and specifications based on characterisation of comparator products, regulatory requirements, design intent and user requirements.
In addition, they will develop test methods and specifications to assess device functionality and product performance, implementing evaluation and procurement of new lab testing equipment as applicable.
Key Responsibilities:
- Provide subject matter expertise to support the development of Combination Products
- Lead a team to plan and execute design verification and reliability strategies
- Develop design requirements and specifications based on characterisation of comparator products
- Develop test methods and specifications to assess device functionality and product performance
Requirements:
- Degree in Science/Engineering (Master's preferred)
- 7+ years' 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 the application of statistical techniques for data analysis
- Experience of writing and supporting regulatory submissions
What We Offer:
We offer a competitive salary and benefits package, including opportunities for professional growth and development.
This is an exciting opportunity for a motivated and experienced Principal Scientist to join our team and contribute to the development of innovative Combination Products.
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