Data Engineer - PMS & QA
About The Company CooperSurgical is a leading provider in the field of fertility and women’s healthcare, committed to supporting women, babies, and families during some of the most significant moments in life. As a division of CooperCompanies, the organization operates with a unified purpose to enable patients to experience life's beautiful moments through innovative healthcare solutions. Guided by core values such as dedication, innovation, friendliness, partnership, and integrity, CooperSurgical offers a comprehensive range of over 600 clinically relevant medical devices designed to assist healthcare providers. These include testing and treatment options, assisted reproductive technology, genomic testing solutions, and a broad spectrum of women’s and family care products. The company’s mission is to enhance patient outcomes and improve quality of life by delivering reliable, high-quality medical devices and services. For more information, visit www.coopersurgical.com. About The Role The Data Engineer Lead – PMS & QA at CooperSurgical plays a pivotal role in analyzing, visualizing, and reporting on Medical Device performance and Post Market Surveillance activities. This position supports the PMS team and the broader QA function by ensuring compliance with regulatory standards and driving continuous improvement initiatives. The role involves developing advanced data visualizations, managing trending processes, and supporting complaint management activities. The Data Engineer Lead collaborates with cross-functional teams including Commercial, Operations, Regulatory Affairs, and Post Market Surveillance to facilitate accurate data reporting and insights that inform strategic decision-making. This role is essential in maintaining regulatory compliance, optimizing product quality, and enhancing process efficiencies across the organization. The position offers the flexibility of working on-site in Trumbull, CT, Livingston, NJ, or remotely within the US, provided the candidate is not residing in the NY-metro area.
Qualifications
- Bachelor's degree in mathematics, statistics, data analytics, engineering, or a relevant field
- Certification in statistical techniques (preferred)
- Minimum of 6+ years of experience in the medical device and/or pharmaceutical industries
- At least 4+ years of experience in data analytics, coding, and evaluating trending data
- Experience with complaint data analytics in the medical device industry (preferred)
- Strong knowledge of applied statistics and coding languages (e.g., SQL, Python, R)
- Expertise in building custom data extracts and visualizations using Power BI or similar platforms
- Familiarity with eQMS software such as Trackwise or Veeva
- Understanding of regulated environments, including FDA, ISO 13485, MDSAP, and EUMDR standards
- Excellent communication skills to articulate technical challenges and solutions to stakeholders
- Ability to develop, report, and track KPIs effectively
Responsibilities
- Develop and maintain Power BI dashboards and data visualizations to monitor complaint management processes and drive process efficiencies
- Lead trending processes, ensuring compliance with regulatory requirements and validation of data analysis
- Support regulatory audits and inspections by providing trending insights and process documentation
- Ensure adherence to CooperSurgical Quality System procedures and external standards such as FDA and ISO requirements
- Collaborate with cross-functional teams to support complaint management and escalate trends as needed
- Design and implement process indicators, develop complaint reports, and facilitate quarterly trend review meetings
- Extract and analyze data from ERP and QMS systems to support trending and reporting activities
- Work with KPI owners to ensure accurate data reporting and presentation to leadership teams
- Oversee data review activities, ensuring data integrity through verification and validation processes
- Contribute to the preparation of post-market documentation including PSUR, SSCP, and CER reports
- Develop training materials to enhance teams’ understanding of trending methods and data analysis techniques
- Lead process improvement projects related to data management and system transitions, such as eQMS upgrades
- Perform other duties as assigned to support organizational goals and compliance initiatives
Benefits
- Comprehensive medical coverage
- 401(k) retirement plan with company match
- Paid parental leave and family support benefits
- Fertility benefits and support progra