This role is part of a high-performance cross-functional team responsible for routine particulate testing of medical devices to ensure the highest quality results. The position is ideal for a highly motivated individual who thrives in a fast-paced, regulated environment, demonstrates strong documentation practices, and maintains exceptional attention to detail while supporting patient safety and product quality.

• Perform routine medical device particulate testing assignments, applying basic interpretation of established procedures to ensure accurate and reliable results.
• Gather and record test data with strong adherence to good documentation practices, analyze results, verify findings, and prepare clear and accurate test reports.
• Exercise broad judgment in troubleshooting test issues and equipment problems, escalating and resolving them in a timely manner.
• Create, maintain, and organize data files, forms, and test documentation to support traceability and compliance requirements.
• Communicate effectively with a wide range of personnel within and outside the plant to coordinate testing activities and share information.
• Identify opportunities for improvement in testing processes and participate in continuous improvement projects to enhance efficiency and quality.
• Use documentation systems to research information, generate change requests, and support updates to procedures and test methods.
• Assist in developing and qualifying data sheets, equipment fixtures, visual standards, and test methods used in laboratory testing.
• Initiate, investigate, and assist in the generation and completion of quality-related records and deviation documentation, ensuring thorough follow-up.
• Assist with product failure analysis by performing tests, gathering data, and contributing to root cause investigations.
• Communicate testing results clearly and promptly to project teams, engineers, and other stakeholders.
• Support engineers in failure analysis and corrective and preventive action (CAPA) activities, including serving as a CAPA project team member when assigned.
• Support process and product qualification activities by executing test protocols and documenting results in accordance with regulatory requirements.
• Serve in support roles during external audits, including acting as a document retriever and auditee, and ensuring readiness of test documentation.
• Perform special quality initiatives under guidance, contributing to projects that enhance product and process quality.
• Consistently demonstrate a primary commitment to patient safety and product quality by maintaining compliance with documented quality policies, processes, and procedures.
• Employ basic analytical laboratory skills, such as reading a meniscus, pipetting accurately, using a balance, and operating a stir plate and other lab equipment.
• Operate and maintain test equipment to ensure proper function, calibration, and reliability for ongoing testing activities.

• Associate degree (AA) or equivalent work experience in a related discipline, with 3+ years of related experience.
• Prior experience working in a laboratory environment, including hands-on analytical laboratory skills such as weighing, pipetting, and applying the scientific method.
• Ability to perform analytical testing with strong attention to detail and accuracy.
• Experience using basic measurement tools such as calipers.
• Chemistry and biology experience relevant to laboratory testing and medical device evaluation.
• Knowledge and practical use of Microsoft Office applications, including Word, Excel, and Outlook.
• DV test protocol training and execution experience in a regulated environment.
• Strong problem-solving skills with the ability to troubleshoot test methods and equipment issues.
• Ability to quickly learn and follow current test processes and procedures in a regulated setting.
• Ability to multitask and manage multiple projects at different stages of development.
• Demonstrated experience analyzing and fulfilling documentation requirements, including compliance with quality standards.
• Ability to communicate detailed technical and testing information clearly to project teams and stakeholders.
• Ability to work effectively in a team environment, collaborating with engineers and technicians.
• Prior experience in test documentation through laboratory notebooks or formal reports.
• Experience in the medical device industry, preferably with direct involvement in testing medical devices.
• Ability to operate and maintain laboratory test equipment