Position Overview:
Insulet Corporation, maker of the OmniPod, is the leader in tubeless insulin pump. Join a fast-paced, mission-driven medical device company where data plays a critical role in improving patient outcomes and operational excellence. As a Data Validation and Compliance Engineer, you’ll work directly with the Data Engineering Leads and cross-functional teams on exciting, high-impact projects that shape the future of our products and data platform.
You’ll be a key contributor in building and validating our Databricks-based data infrastructure, ensuring it meets the rigorous standards of the medical device industry. This is a unique opportunity to blend technical expertise with regulatory insight, helping to drive innovation while maintaining the highest standards of data integrity and compliance.
We offer a dynamic and collaborative work environment, where your attention to detail and passion for quality will directly influence product development, clinical insights, and operational efficiency. If you’re looking for a role where your work truly matters—and where you’ll grow alongside a team of talented engineers and healthcare professionals—this is the place for you.

Responsibilities:

• Design and implement robust validation protocols for big data pipelines in Databricks.
• Ensure data integrity, accuracy, and completeness across ingestion, transformation, and storage layers.
• Develop automated data quality checks and anomaly detection mechanisms.
• Ensure all data processes comply with FDA, ISO 13485, HIPAA, and other relevant medical device regulations.
• Collaborate with Quality Assurance and Regulatory Affairs teams to align data practices with audit and documentation standards.
• Maintain traceability matrices and validation documentation for regulatory submissions.
• Define and enforce data governance policies within the Databricks environment.
• Monitor and audit data access, lineage, and usage to ensure compliance with internal and external standards.
• Work closely with data engineers, scientists, and clinical teams to understand data requirements and validation needs.
• Prepare validation reports, risk assessments, and CAPA documentation.
• Support internal and external audits with detailed technical evidence and documentation.

Education and Experience:

• Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Data Science, or a related field.
• 3+ years of experience in data engineering or data quality roles, preferably in the healthcare or medical device industry.
• Proven experience with Databricks, Apache Spark, and big data validation frameworks.
• Familiarity with regulatory standards such as FDA 21 CFR Part 11, ISO 14971, and GxP.
• HIPAA experience a plus

Skills/Competencies:

• Proficiency in Python, SQL, and Spark.
• Experience with ETL tools, data warehousing, and cloud platforms (Azure, AWS).
• Strong understanding of data modeling, schema validation, and metadata management.
• Deep knowledge of medical device validation lifecycle (IQ/OQ/PQ).
• Experience with documentation practices for regulated environments.
• Ability to interpret and apply regulatory standards to data systems.
• Exceptional attention to detail and analytical thinking.
• Strong communication and documentation skills.
• Ability to work cross-functionally in a fast-paced, regulated environment.

Additional Information:
The US base salary range for this full-time position is $90,600.00 - $135,900.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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• Design and implement robust validation protocols for big data pipelines in Databricks.
• Ensure data integrity, accuracy, and completeness across ingestion, transformation, and storage layers.
• Develop automated data quality checks and anomaly detection mechanisms.
• Ensure all data processes comply with FDA, ISO 13485, HIPAA, and other relevant medical device regulations.
• Collaborate with Quality Assurance and Regulatory Affairs teams to align data practices with audit and documentation standards.
• Maintain traceability matrices and validation documentation for regulatory submissions.
• Define and enforce data governance policies within the Databricks environment.
• Monitor and audit data access, lineage, and usage to ensure compliance with internal and external standards.
• Work closely with data engineers, scientists, and clinical teams to understand data requirements and validation needs.
• Prepare validation reports, risk assessments, and CAPA documentation.
• Support internal and external audits with detailed technical evidence and documentation