Position SummaryWe are seeking an experienced Lab Project Specialist to lead the planning, development, and execution of verification activities for medical device products. This individual will serve as a technical expert in device testing, design inputs, risk analyses, and product requirements into robust verification strategies and test methods.The ideal candidate possesses a strong engineering background, understands how medical devices function from both a design and user perspective, and can independently determine what testing is required to demonstrate that design requirements have been met. This role works closely with R&D, Lab, Quality, Regulatory Affairs, and external partners throughout the product development lifecycle.Key ResponsibilitiesDesign Verification Develop and execute design verification strategies for new and existing medical devices.Review product requirements, design inputs, and risk analyses to determine appropriate verification activities.Create verification protocols, test plans, acceptance criteria, and reports in compliance with applicable design control requirements.Ensure objective evidence is generated to demonstrate compliance with design requirements.Test Method Development and Test ExecutionDesign, develop, optimize, and validate test methods for mechanical, functional, usability, environmental, reliability, and performance testing.Identify and implement appropriate measurement systems, instrumentation, fixtures, and data acquisition methods.Evaluate test method capability, repeatability, and reproducibility (e.g., GR&R).Develop custom test equipment and fixtures as needed.Support TMV and testing execution.Data Analysis and Technical ReportingAnalyze test data using statistical and engineering methods.Support root cause analysis and recommend corrective actions.Prepare clear technical reports and present findings to project teams and management.Cross-Functional CollaborationCollaborate with Design Engineering, Quality, Regulatory Affairs, and Lab staff.Coordinate testing activities with external laboratories, consultants, and suppliers.Mentor junior engineers and provide leadership in verification and testing practices.Support overall project planning from a testing strategy perspective.Compliance and QualityEnsure verification activities comply with applicable standards, guidance documents, and internal procedures.Participate in Design Control, Risk Management, and Design History File (DHF) activities.Expertise in ISO 13485, ISO 14971
