Data Engineer Lead- PMS & QA

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 through clinically relevant medical devices and solutions.

Work location: Trumbull, CT (on-site), Livingston, NJ (on-site) or Remote in US (if not residing in NY-metro area). This position may require 5% domestic and/or foreign travel.

About the role

The Data Engineer Lead - PMS & QA leads data analysis, visualization, and reporting of Medical Device performance and Post Market Surveillance (PMS) activities within the PMS team and the broader Quality Assurance (QA) function. This role supports CooperSurgical Complaint Management and other Quality areas by partnering with Commercial, Operations, Regulatory Affairs, and Post Market Surveillance teams to ensure regulatory compliance and drive continuous product and process improvements.

Responsibilities

• Develop custom Power BI dashboards and data visualizations to monitor and improve the Complaint Management process, ensuring adherence to requirements and driving efficiencies.
• Lead the Trending Process, maintain trending procedures, and validate data analysis in compliance with regulatory requirements; represent trending in Notified Body and other regulatory audits/inspections.
• Ensure compliance with CooperSurgical Quality System procedures and external standards, including FDA, ISO 13485, MDSAP, and EUMDR.
• Collaborate with cross-functional teams to support complaint daily management and timely escalation of complaint trends.
• Work with Complaint Management leadership to implement leading and lagging process indicators and develop complaint reports addressing key questions and KPIs.
• Develop and implement quarterly complaint trend review meetings.
• Extract and analyze data from various ERP/QMS systems for trending and reporting.
• Facilitate efficient and accurate data reporting to CooperSurgical leadership teams in partnership with KPI owners.
• Oversee data review for monitoring, trending, and escalation of process indicators, ensuring data integrity through verification and validation.
• Support critical post-market documents (PSUR, SSCP, CER, etc.) with required data input.
• Develop training materials for trending methods and analysis.
• Lead process improvement projects, such as transitioning to a new eQMS, as needed.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in mathematics, statistics, data analytics, engineering, or a relevant field (required). Certification in statistical techniques (preferred).
• 6+ years of experience in the medical device and/or pharmaceutical industries (medical device experience preferred).
• 4+ years of experience in data analytics, coding, evaluating trending data, and deriving strategic insights (experience with complaint data analytics in the medical device industry preferred).

Skills

• Expertise in applied statistics, coding, and interacting with databases to build custom data extracts for Power BI and other visualization platforms.
• Ability to articulate technical challenges and solutions with IT and internal/external stakeholders.
• Knowledge of eQMS software (e.g., Trackwise, Veeva) and understanding of build requirements for eQMS transitions.
• Experience developing, reporting, and tracking KPIs, and delivering data-driven presentations to leadership teams.
• Knowledge of regulated environments and requirements, such as FDA Quality System Regulations (21 CFR Part 820), MDD/MDR, and international standards (ISO 13485, ISO 14971, IEC 62304).
• Customer-focused mindset for all internal and external interactions.

Work Environment

Prolonged periods of sitting, especially in front of a computer.

Benefits

CooperSurgical offers a comprehensive total compensation plan, including:

• Medical coverage
• 401(k) retirement plan
• Parental leave
• Fertility benefits
• Paid time off for vacation, personal, sick, and holidays
• Multiple other perks and benefits

Pay

The starting base pay for this role is between $120,000.00 - $160,000.00 annually. The actual base pay includes many factors and is subject to change. This position may also be eligible for other types of compensation and benefits.