Our client is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
Responsibilities
Research & Development:
* Conduct background research and literature reviews to support product development.
* Assist in identifying unmet clinical needs and opportunities for innovation.
* Support the design and development of medical device prototypes, components, and systems.
* Analyse experimental and validation data to guide decision-making.
* Collaborate with cross-functional teams (engineering, regulatory, quality, clinical, marketing).
Data Analysis & Reporting:
* Perform statistical analysis on bench testing, verification, and validation studies.
* Compile and interpret laboratory data to inform development decisions.
* Prepare technical reports, protocols, and documentation for regulatory submissions.
Testing & Validation:
* Assist in designing experiments and test methods for performance, biocompatibility, and reliability.
* Conduct testing in accordance with applicable regulatory standards (e.g., ISO 10993, IEC
* Document findings and recommend design modifications based on test results.
Experience
* 7-10 years' experience in analytical lab test method development, verification and validation.
* Experience is development, verification & validation of analytical test methods for injectables, hydrogel, polymers etc.
* Hands on Experience in HPLC, Dissolution, GPC etc test method development and validation.
* Experience in troubleshooting issues associated with HPLC, Dissolution, GPC test methods and test equipment.
* Experience in development of analytical tests like Karl Fisher, NMR, GC, DSC.
* Experience is working GLP environment.
* Experience in reviewing analytical protocol, report and data reports.
* Experience in reviewing lot release data as part of analytical testing.
* Experience and deep understanding of USP, ICH guidelines for HPLC, Dissolution and other analytical test methods.
* Fully onsite role due lab-based requirements
To discover more about this opportunity please apply online or contact Darragh on for a confidential discussion.