
Senior Product Development Engineer
3 days ago
Job Opportunity:
We are seeking a highly skilled professional to fill the role of Principal Scientist Design, with expertise in mechanical design and development of combination products.
About the RoleAs a key member of our team, you will provide subject matter expertise to support the development of Combination Products. Your responsibilities will include:
- Providing mechanical design and development for combination products.
- Leading a team to plan and execute design verification and reliability strategies.
- Serving as a technical interface between drug product and device teams during combination product development.
- Developing design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent, and user requirements.
- Creating test methods and specifications to assess device functionality and product performance.
- Evaluating material assessment of device components, including biological evaluation, extractables profiling, and material certification.
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
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