Senior Manufacturing System Engineer
Core
Own and validate digital systems supporting medical device manufacturing operations, ensuring compliance with GMP, FDA, and ISO standards.
Role type
Senior Manufacturing System Engineer
Builds
Validated manufacturing applications (ERP, MES, databases), reporting platforms, and digital workflows for medical device production.
Domain
Medical device manufacturing / Regulatory Compliance / Enterprise Systems
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
System lifecycle management, Computer System Validation (CSV), SAP Business One, SQL, GMP/FDA/ISO 13485/21 CFR Part 11 compliance, Project Management
Preferred skills
Power BI, Power Apps, Power Automate, automation technology implementation
Technologies
SAP Business One, SQL, Power BI, Power Apps, Power Automate
Responsibilities
Act as System Owner for assigned manufacturing applications; Lead Computer System Validation (CSV) activities; Develop and maintain manufacturing software systems and digital workflows; Support SAP Business One processes for inventory and production; Develop SQL queries and reporting solutions; Partner with cross-functional teams to deliver validated systems; Monitor system performance and data integrity.
Seniority
Senior, hands-on IC
