Data Engineer - Remote
5+ years
United States
Full-time
Remote
1 month ago
About the role
About The Company
CooperSurgical is a leading provider in the field of fertility and women's healthcare, dedicated to supporting women, babies, and families during the most critical moments of their healthcare journeys. As a division of CooperCompanies, we are driven by a shared mission to enable patients to experience life's most meaningful moments. Our core values—dedicated, innovative, friendly, partnership-oriented, and committed to doing the right thing—guide our efforts to deliver comprehensive healthcare solutions. We offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as advanced assisted reproductive technology and genomic testing solutions. Our offerings span the entire spectrum of women’s and family health, from contraception to fertility, birth solutions, and beyond. For more information, visit www.coopersurgical.com.
About The Role
The Data Engineer Lead – PMS & QA is a pivotal role responsible for leading data analysis, visualization, and reporting activities related to Medical Device performance and Post Market Surveillance (PMS). This role supports the PMS team and the broader Quality Assurance (QA) function by ensuring regulatory compliance, facilitating continuous product and process improvements, and providing critical insights through data-driven decision-making. The successful candidate will collaborate closely with cross-functional teams including Commercial, Operations, Regulatory Affairs, and Post Market Surveillance to develop dashboards, monitor trending processes, and support complaint management activities. The role involves navigating complex data systems, validating data integrity, and leading initiatives to enhance process efficiency and compliance with industry standards such as FDA, ISO 13485, MDSAP, and EUMDR.
Qualifications
Responsibilities
Benefits
Equal Opportunity
CooperSurgical is an equal opportunity employer committed to fostering an inclusive environment. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, citizenship, marital status, veteran status, or any other protected characteristic. We welcome applications from all qualified individuals and strive to create a workplace that reflects diversity and inclusion.
CooperSurgical is a leading provider in the field of fertility and women's healthcare, dedicated to supporting women, babies, and families during the most critical moments of their healthcare journeys. As a division of CooperCompanies, we are driven by a shared mission to enable patients to experience life's most meaningful moments. Our core values—dedicated, innovative, friendly, partnership-oriented, and committed to doing the right thing—guide our efforts to deliver comprehensive healthcare solutions. We offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as advanced assisted reproductive technology and genomic testing solutions. Our offerings span the entire spectrum of women’s and family health, from contraception to fertility, birth solutions, and beyond. For more information, visit www.coopersurgical.com.
About The Role
The Data Engineer Lead – PMS & QA is a pivotal role responsible for leading data analysis, visualization, and reporting activities related to Medical Device performance and Post Market Surveillance (PMS). This role supports the PMS team and the broader Quality Assurance (QA) function by ensuring regulatory compliance, facilitating continuous product and process improvements, and providing critical insights through data-driven decision-making. The successful candidate will collaborate closely with cross-functional teams including Commercial, Operations, Regulatory Affairs, and Post Market Surveillance to develop dashboards, monitor trending processes, and support complaint management activities. The role involves navigating complex data systems, validating data integrity, and leading initiatives to enhance process efficiency and compliance with industry standards such as FDA, ISO 13485, MDSAP, and EUMDR.
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 or pharmaceutical industry, with medical device experience preferred
- At least 4+ years of experience in data analytics, coding, trend evaluation, and strategic insights generation
- Proficiency in Power BI and other data visualization platforms
- Experience working with databases and extracting data for analysis
- Knowledge of regulated environments and standards such as FDA QSR, ISO 13485, MDSAP, and EUMDR
- Familiarity with eQMS software (e.g., Trackwise, Veeva)
- Strong analytical, communication, and stakeholder management skills
Responsibilities
- Develop and maintain custom Power BI dashboards and visualizations to monitor complaint management processes and drive process improvements
- Lead trending processes, ensuring compliance with regulatory requirements, and prepare for audits and inspections
- Ensure adherence to CooperSurgical Quality System procedures and external standards such as FDA, ISO 13485, and MDSAP
- Collaborate with cross-functional teams to support complaint management activities and escalate trends as necessary
- Work with leadership to implement and track process indicators, KPIs, and develop comprehensive complaint reports
- Facilitate extraction and analysis of data from various ERP/QMS systems for trending and monitoring
- Oversee data validation activities to ensure accuracy and integrity of reporting outputs
- Support critical post-market documentation including PSUR, SSCP, CER, and others
- Develop training materials and conduct sessions to enhance team capabilities in trending and data analysis
- Lead process improvement projects across different departments, including system transitions and upgrades
- Perform additional duties as assigned to support organizational goals
Benefits
- Comprehensive medical coverage
- 401(k) retirement plan with company match
- Paid parental leave and fertility benefits
- Paid time off including vacation, personal days, sick leave, and holidays
- Opportunities for professional development and career growth
- Participation in a collaborative and innovative work environment
Equal Opportunity
CooperSurgical is an equal opportunity employer committed to fostering an inclusive environment. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, citizenship, marital status, veteran status, or any other protected characteristic. We welcome applications from all qualified individuals and strive to create a workplace that reflects diversity and inclusion.
Skills
Information TechnologyTechnology, Information and Internet