Our client is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.ResponsibilitiesResearch & 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.Experience7-10 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 requirementsTo discover more about this opportunity please apply online or contact Darragh on for a confidential discussion.