Data Quality and Compliance Engineer - Acton, Mass. or San Diego, CA (Hybrid)

Insulet Corporation-posted 4 months ago

$90,600 - $135,900/Yr

Full-time

Acton, MA

Miscellaneous Manufacturing

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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.

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.

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.

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.

The US base salary range for this full-time position is $90,600.00 - $135,900.00.
Salary ranges are determined by role, level, and location.
Individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

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Data Quality and Compliance Engineer - Acton, Mass. or San Diego, CA (Hybrid)

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