Millstone is seeking a detail-oriented and technically capable Laboratory Technician II to join our Microbiology Medical Device Testing team. The Laboratory Technician II performs hands-on laboratory testing and evaluations of medical devices in support of product development, verification, validation, quality assurance, and regulatory requirements.
The ideal candidate has strong laboratory skills, experience following established test methods and procedures, and the ability to independently perform technical testing while maintaining accurate and compliant laboratory documentation.
Key Responsibilities
- Perform mechanical, physical, functional, and environmental testing of medical devices in accordance with approved protocols, test methods, and SOPs.
- Set up, operate, and perform routine maintenance of laboratory equipment, and instrumentation.
- Perform testing in accordance with applicable ASTM, ISO, IEC, FDA, USP, and internal laboratory procedures.
- Accurately collect, record, and maintain test data using approved forms, electronic systems, and laboratory documentation.
- Perform calculations and basic data analysis associated with laboratory testing.
- Troubleshoot laboratory equipment, test fixtures, and test setups to identify and resolve routine technical issues.
- Identify and communicate equipment or test-method issues that may affect testing activities.
- Assist with the development, verification, and validation of laboratory test methods and equipment.
- Support equipment qualification, calibration, and routine performance checks as required.
- Follow Good Documentation Practices (GDP), Good Laboratory Practices (GLP), applicable Quality System requirements, and laboratory procedures.
- Maintain laboratory equipment, work areas, supplies, and materials in an organized and operational condition.
- Perform routine laboratory maintenance and assist with equipment troubleshooting and upkeep.
- Maintain awareness of laboratory inventory and communicate material or equipment needs to appropriate laboratory personnel.
- Follow established safety procedures and maintain a clean, safe, and organized laboratory environment.
- Participate in laboratory process improvement activities focused on testing efficiency, equipment utilization, and technical execution.
- Support investigations related to laboratory testing, equipment performance, or procedural issues as directed.
- Perform testing with minimal supervision while appropriately escalating technical issues when additional support is required.
- Assist with training and onboarding of less-experienced laboratory personnel by demonstrating laboratory techniques, equipment operation, and established testing procedures.
- Serve as a technical resource to other laboratory technicians by sharing established testing techniques and best practices.
Qualifications
Education
- Bachelor's degree in Life Sciences, Biology, Chemistry, Biomedical Engineering, or a related scientific discipline.
Experience
- 2–5 years of laboratory experience, preferably within the medical device, biotechnology, pharmaceutical, or other regulated manufacturing industry.
- Experience performing laboratory testing using established procedures, protocols, or standardized test methods.
- Experience operating laboratory equipment and instrumentation.
Technical Skills
- Ability to independently follow technical procedures, test methods, protocols, and SOPs.
- Demonstrated ability to perform hands-on laboratory testing accurately and consistently.
- Experience with laboratory equipment, instrumentation, and test fixtures.
- Ability to troubleshoot routine equipment and testing issues.
- Strong data collection, recording, and documentation skills.
- Ability to perform basic calculations and technical data analysis.
- Familiarity with Microsoft Office and electronic laboratory systems.
- Ability to recognize testing deviations, equipment issues, or procedural concerns and appropriately escalate them.
- Strong organizational skills and attention to detail.
- Ability to manage multiple testing activities and priorities with minimal supervision.
Preferred Qualifications
- Experience working in an ISO 13485, ISO 17025, FDA-regulated, or other controlled laboratory environment.
- Knowledge of ASTM, ISO, IEC, USP, or other applicable testing standards.
- Experience with universal testing machines, environmental chambers, force gauges, pressure systems, or other laboratory instrumentation.
- Experience performing medical device verification and validation testing.
- Experience with laboratory information management systems (LIMS) or electronic laboratory systems.
- Experience with equipment qualification, calibration, or validation activities.
- Experience troubleshooting laboratory equipment and test fixtures.
Technical Competencies
- Hands-on laboratory testing
- Technical aptitude
- Equipment operation and troubleshooting
- Test method execution
- Data collection and documentation
- Basic technical data analysis
- Attention to detail and accuracy
- Problem-solving
- Time management and organization
- Ability to work independently
- Laboratory safety and quality awareness
- Teamwork and technical knowledge sharing
Work Environment
- Performs hands-on testing in a laboratory environment.
- May require standing, sitting, lifting, moving laboratory equipment or materials, and working at laboratory workstations for extended periods.
- May work with laboratory instrumentation, mechanical test equipment, environmental chambers, chemicals, and medical device samples in accordance with applicable safety procedures.
- Requires adherence to established laboratory safety, quality, and testing procedures.
Pay: $28.00 - $32.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Vision insurance
Work Location: In person
