Senior Device Development Specialist
5 days ago
We are currently seeking a skilled Principal R&D Engineer to work with us at Life Science Recruitment. This individual will report directly to an R&D Director and be responsible for the development of a portfolio of devices. The successful candidate will also serve as a subject matter expert in the organization.
Key Responsibilities
- Take charge of providing technical leadership to support device development across the portfolio.
- Be responsible for developing device design requirements and specifications and performing robust device and product characterization throughout the design development program.
- Lead the technical interface between drug product and device teams during combination product development, focusing on primary container interface and compatibility, batch manufacture, and shelf life studies.
- Offer technical support to manufacturing sites during filling and assembly process development, including designing experiments and trials to identify process controls, reliability requirements, sampling plans, and release specifications.
- Responsible for metrology, engineering verification, design verification, device functional stability, defect management, biological evaluation, extractables/leachable, specifications & method development, and transport & shipping studies.
- Trend and statistically analyze analytical and manufacturing data, compiling technical reports to support combination product development lifecycle.
- Critically review the device analytical and manufacturing control strategy for projects, ensuring regulatory requirements are incorporated into development plans.
- Compile and review/approve technical documentation within the group.
- Ensure all activities within the team are conducted and executed to the appropriate quality standards within the Quality Management system.
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Medical Device Product Specialist
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