Equipment Engineer
CooperCompaniesAbout the role
About CooperSurgical:
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Job Summary:
Working closely with research & development, laboratory operations, and quality assurance, the Equipment Engineer is responsible for ensuring the optimal performance, reliability, and compliance of laboratory instrumentation and equipment used in genomics research and clinical testing. The Equipment Engineer partners with laboratory staff, quality teams, and vendors to troubleshoot issues, implement preventive maintenance programs, and support the integration of new technologies. nd contributing to the laboratory’s regulatory readiness. This role supports laboratory operations by overseeing equipment lifecycle management, troubleshooting, and continuous improvement initiatives and partners with laboratory scientists, operations staff, and vendors to maintain equipment readiness and ensure that laboratory instrumentation meets regulatory, quality, and safety standards.
Essential Functions & Accountabilities:
- Conduct routine inspections of equipment and instrumentation to identify faults and potential issues.
- Execute and/or support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and existing equipment.
- Perform routine and preventive maintenance to minimize downtime and ensure optimal equipment performance.
- Troubleshoot technical issues and coordinate repairs with internal resources or external vendors.
- Perform technical repairs of laboratory instrumentation and subsequent repair verifications/qualifications.
- Respond rapidly to equipment failures to minimize disruption of laboratory operations.
- Partner with laboratory operations to monitor equipment utilization and performance metrics.
- Analyze equipment performance data to identify trends, recommend, and implement upgrades, modifications, or replacements to enhance laboratory efficiency and capacity.
- Support the introduction and validation of new instruments and emerging technologies.
- Collaborate with validation teams to ensure integrity in equipment and system validation.
- Maintain appropriate documentation and traceability for all qualification activities.
- Ensure all activities are conducted in compliance with CLIA, CAP, ISO 15189, and internal quality system requirements.
- Support internal and external audits by providing equipment-related documentation and acting as a Subject Matter Expert (SME) for equipment troubleshooting and optimization.
- Initiate and support deviation investigations and corrective/preventive actions (CAPAs) related to equipment performance issues.
- Collaborate with QA/QC and Lab Operations to assess equipment-related risks and implement controls to minimize measurement uncertainty.
- Train lab staff on proper handling, usage, and storage of calibrated equipment to prevent misuse and drift.
- Foster a culture of accountability, collaboration, and continuous learning.
Travel: Travel may be required to attend meetings or visit manufacturing sites. <10% travel is anticipated.
Qualifications
Knowledge, Skills and Abilities:
- atory instrumentation used in genomics, such as automated liquid handling platforms, thermal cyclers, sequencers, and related diagnostic equipment.
- Strong understanding of electronics principles, digital and analog systems, programing and troubleshooting techniques and ability to interpret technical manuals, schematics, and equipment specifications.
- Fine motor skills and experienced dexterity needed for frequent hands-on work with sensitive and high-value instruments such as NGS sequencers, pipettes, balances, incubators, thermocyclers, and automated liquid handlers.
- Strong analytical skills in diagnosing complex instrumentation or system issues and implementing effective corrective actions.
- Ability to write,
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