Job Description
Role Summary
Responsible for managing and executing Product Data Management (PDM) and Engineering Change processes for regulated pathology and medical equipment. Ensures compliant master data, documentation, and change implementation across the product lifecycle within ERP and PLM systems, in alignment with Quality Management System (QMS) and regulatory requirements.
Key Responsibilities
- Implement, manage, and sustain the Engineering Change Management (ECN/ECO) process, including master data and document control across the complete product lifecycle within PLM and ERP systems (Agile & SAP). Lead and coordinate Engineering Change Orders (ECOs) for the release and maintenance of sales and production Bills of Materials (BOMs).
- Author, review, and maintain documentation related to product improvements, repairs, deviations, and new product development, covering parts, assemblies, tools, and finished medical devices.
- Owns the documentation, governance, and global standardization of Pathology, Reagent Partner, and CDx master data, ensuring compliant creation, maintenance, and communication of regulated product attributes across Agile PLM, SAP, and POMS, in alignment with QMS, change control, and medical device regulatory requirements throughout the product lifecycle.
- Supports line of business initiatives and global SAP rollout programs by partnering with business and SAP teams to define, implement, and govern master data updates and changes in strict adherence to GMD processes.
- Ensure strict adherence to Quality Management System (QMS) requirements, including change control, documentation standards, traceability, and audit readiness for regulated medical products.
- Apply strong knowledge of medical and regulated product lifecycle processes, ensuring compliant execution of master data, BOMs, and change activities for pathology and medical equipment.
- Coordinate cross‑functional collaboration between R&D Engineering, Manufacturing, Procurement, Planning, Quality, and Finance to ensure timely, accurate, and compliant change implementation.
- Support and manage documentation aligned with GMP, GLP, and GCP requirements, including procedure manuals, controlled records, and formal change authorizations in accordance with internal policies and regulatory standards.
- Analyze proposed engineering changes for technical feasibility, regulatory impact, manufacturability, cost, and schedule, partnering with stakeholders to gather and validate required inputs.
- Configure and maintain new and revised BOM structures, ensuring accurate system data setup and controlled document maintenance.
- Collaborate closely with manufacturing teams to ensure seamless implementation of approved changes, including BOM updates, routing alignment, and associated documentation.
- Ensure ongoing data and document integrity between PLM (Agile) and ERP (SAP) systems across ordering, manufacturing, distribution, and service activities.
- Assign and manage internal part numbers, load and maintain material master records, and ensure completeness of basic ERP master data views.
- Maintain and update product information, descriptions, and pricing data within ERP systems in alignment with approved change records.
- Drive process and system improvements to enhance accuracy, consistency, and compliance of product data and documentation throughout the product lifecycle.
Core Competencies
- Medical Device / Regulated Product Change Management
- Engineering Change Control (ECO/ECN)
- QMS, GMP, GLP, GCP Compliance
- PLM (Agile) & ERP (SAP) Master Data Management
- Cross‑functional Coordination & Stakeholder Management
- Documentation Control & Audit Readiness
Qualifications
Bachelor's or Master's Degree or equivalent. having relevant experience on medical equipment's / pathology
Post-graduate, certification and/or license may be required.
Typically, at least 8+ years relevant experience for entry into this level.
Additional Details
This job has a full time weekly schedule.
Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Travel Required:
Occasional
Shift:
Day
Duration:
No End Date
Job Function:
Manufacturing