SoCode are proud to represent a global leader in the healthcare industry, who have recently promoted two Principle Scientists in the Device and Product Performance team, leaving a gap for two additional Principal Scientists! This is a great opportunity for an expert looking to make a significant impact in the development of Combination Products.
The ideal candidate will have:
* A Degree in Science/Engineering (Master’s preferred)
* 7+ years of experience in drug delivery and/or medical device development
* 3-5 years of Combination Product Performance
* Working knowledge of design control requirements (FDA 21 CFR part 820 and ISO 13485)
* Strong background in the development and validation of analytical methods
* Expertise in statistical techniques for data analysis
* Experience with regulatory submissions and compliance
* Experience being an SME, presenting to technical and non-technical stakeholders.
* Knowledge in device functionality testing and material assessments
* Expertise in developing test methods and device characterisation
What will you be doing?
* Provide subject matter expertise to support the development of Combination Products
* Lead a team to plan and execute design verification and reliability strategies
* Manage technical interface between drug product and device teams during combination product development
* Develop design requirements and specifications based on regulatory, user needs, and comparator product characterisation
* Create test methods to assess device functionality and product performance, including evaluating and implementing new lab testing equipment
* Perform material assessments, biological evaluations, and extractables profiling for device components
* Provide technical support during manufacturing and assembly process development
* Use statistical techniques to inform design decisions and validate test methods
* Ensure all activities adhere to GDD Quality Management system standards
Interested in the role? Then you can either:
* Submit your CV by applying to this job advert.
* Connect with us on LinkedIn for an informal discussion.
* Call our office for more information – Google SoCode and ask for more details.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering, Design, and Project Management
Industries
Medical Equipment Manufacturing
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