Staff Business Systems & Process Analyst
Core
Manages engineering documentation, product structures, and change control activities to ensure data integrity and compliance for engineering and manufacturing teams.
Role type
Staff Business Systems & Process Analyst (Engineering Document Control)
Builds
Controlled engineering documentation, Bills of Materials (BOMs), and change control records for medical device development.
Domain
Medical device industry / Engineering data management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Engineering documentation control, Change management, Product data management (PDM), ALM tools, PLM systems, ERP systems, CAD systems, BOM management, Process improvement, Data governance
Preferred skills
Medical device regulatory requirements (FDA 21 CFR Part 820/11, ISO 13485), Quality organization documentation reviews, Training compliance
Technologies
Agile PLM, Oracle Cloud PLM, Polarion, SolidWorks, Windchill, Microsoft Office, Adobe Acrobat
Responsibilities
Provide end-to-end support for engineering documentation and change control activities; Partner with engineering teams to assess documentation and BOM needs; Maintain and govern controlled documents in accordance with quality system requirements; Identify gaps and support continuous improvement initiatives; Support engineering business systems enhancements through requirements analysis and UAT; Ensure alignment between CAD models, drawings, and released documentation; Train and mentor colleagues on documentation standards and tool usage.
Seniority
Staff, hands-on IC with mentorship