Medical Device Data Analyst

We are seeking a highly motivated Product Compliance & Field Quality Engineer to join a team developing industry-leading X-ray generation subsystems (tubes and generators). This role focuses on supporting the large installed base of imaging systems by ensuring ongoing regulatory compliance and driving continuous product quality improvement. The engineer will lead compliance-driven design changes and also work closely with field service and installed base teams to collect, analyze, and interpret field performance data to support escalations and long-term quality initiatives. Key Responsibilities • Product Compliance & Design Change • Drive engineering design changes required by regulatory and compliance notifications (e.g. RoHS, REACH, PFAS, plastics, labeling and reporting). • Assess regulatory impact on existing products and ensure documentation and reporting are kept current. • Manage compliance updates within PLM systems and support engineering change processes. • Field Data & Quality Engineering • Collaborate with field service and installed base engineering teams to collect and analyze field failure data. • Lead data cleansing and validation for X-ray tubes and generators deployed in the field. • Identify failure trends, quality risks, and opportunities for product improvement. • Support customer escalations using structured data analysis and reporting. Tools & Technologies • Strong proficiency with MS Office (especially Excel and PowerPoint). • Experience with PLM systems (3DExperience, PTC Windchill, or similar). • Working knowledge of RoHS, REACH, and PFAS regulations. • Familiarity with SQL and data visualization tools such as Power BI or Tableau. Required Skills & Experience • Engineering background (Mechanical, Electrical, Biomedical, or similar). • Experience in product compliance, quality engineering, or sustaining engineering. • Strong analytical and problem-solving skills. • Excellent communication skills with the ability to work cross-functionally. • Comfortable working with both technical teams and business stakeholders. Nice to Have • Experience in medical devices or regulated industries. • Understanding of field service operations or installed base analytics. • Experience supporting product lifecycle and post-market surveillance.