Product Data Management- Change Analyst
Agilent Technologies · Manesar, Haryana, India
Full-time · Staff · Posted 11 days ago
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 degree in
Engineering /B.Tech (Mechanical Engineering, Biotechnology, Industrial
Management, or a related field). 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 Graduate
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