Education Qualification:
Master’s degree in industrial engineering/plastic engineering/instrumentation required
• Knowledge of primary regulatory requirements in pharma such as 21 CFR, ISO 13485 standards, IEC standards are preferable
• Knowledge of Polymers, injection molding and assembly automation must
Relevant Work Experience:
Experience at reputed of minimum 3 years in device development, automation for manufacturing/assembly and the medical devices is a must.
• Experience in medical device manufacturing (direct operations/team handling) highly welcome
Roles & Responsibilities:
I. Robustness protocol design, development, execution and reporting
- Build test protocols, custom test rig concepts to test the performance and robustness of medical devices.
- Conduct robustness studies with the device team and report the outcomes to regulatory and QA in the required manner
II. Device design history file at Partner locations
- Work with regulatory and QA functions to complete device documentation such as functional specifications, component certifications, biocompatibility study, robustness study protocols
- Recording of results and regulatory submission files
III. Scale-up assurance and quality checkpoint design at selected vendors for device manufacturing.
- Conduct Failure mode and opportunity analysis, patient safety study.
- Build designs of devices and electronics for scale-up which have the right quality checkpoints
IV. Device performance and patient handling documentation
- Keep track of device-wise ergonomic and DMF iterations.
- Build protocols for device similarity, patient handling study for regulatory submission
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