Job Description
As a Principal Scientist/Engineer Medical Device Development, you will lead the design, development, and performance evaluation of drug-device combination products. This role requires technical expertise in ensuring that products meet regulatory and quality standards.
You will be responsible for providing subject matter expertise to support the development of Combination Products. This includes planning and executing design verification and reliability strategies. Additionally, you will be the technical interface between drug product and device teams during combination product development.
Responsibilities include:
* Providing subject matter expertise to support the development of Combination Products
* Planning and executing design verification and reliability strategies
* Being the technical interface between drug product and device teams during combination product development
* Responsible for the development of design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements
* Developing test methods and specifications to assess device functionality and product performance
* Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification
* Providing technical support to manufacturing sites during filling and assembly process development
* Using statistical techniques or data analysis to inform design decision making and conclusions for deliverables like test method validations, design characterizations and verification, and reliability
Required Skills and Qualifications
The ideal candidate will have a degree in Science/Engineering (Master's preferred) and 7+ years' experience in pharmaceutical and/or medical device development. A working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage.
* 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
Benefits
This role offers the opportunity to work as part of a flexible, dynamic team while taking responsibility for individual tasks in a Subject Matter Expert role. Some travel will be required as part of this role.
* Highly driven and motivated person who can work as part of a flexible, dynamic team
* Well-developed communication skills to lead or facilitate effective discussions
* Some travel will be required as part of this role