Sap Plm

Kannanware•New York, NY

11d

About The Position

Key Responsibilities SAP PLM Architecture & Design Define and own the SAP PLM system architecture, roadmap, and standards across the enterprise. Lead solution design for SAP PLM modules including: SAP PLM 7.x / SAP S/4HANA PLM Engineering Records (ER) Engineering Change Management (ECM) Document Management System (DMS) Recipe/Specification Management (where relevant) Classification & Variant Configuration Ensure integration of PLM with SAP modules such as PP, QM, MM, SD, EWM, and with external systems (CAD, MES, LIMS, eQMS). Product Lifecycle & Compliance Translate medical device product lifecycle requirements into SAP PLM processes, including: Design controls (per 21 CFR Part 820, ISO 13485) Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR) Risk management (ISO 14971) Traceability across requirements, changes, and documentation Ensure SAP PLM aligns with FDA QSR and EU MDR documentation, audit, and quality compliance needs. Technical Leadership Act as the SME for SAP PLM and champion best practices for data governance, versioning, change management, and digital thread integration. Lead configuration, functional design, and system enhancements. Provide technical leadership to internal teams and external implementation partners. Develop integration strategies with CAD (e.g., SolidWorks, Creo, AutoCAD), ALM, and document control systems. Project Delivery & Stakeholder Engagement Work with business teams to gather requirements, define user stories, and convert them into technical solutions. Lead workshops, design sessions, and cross -functional meetings. Provide guidance for testing (IQ/OQ/PQ), validation documentation, and change control under medical device regulations. Ensure projects are delivered on time, within scope, and aligned with the enterprise architecture. Support & Continuous Improvement Provide Tier -3 support for SAP PLM and related integrations. Identify opportunities for process optimization and automation (workflow, approvals, digital signatures). Maintain documentation for system design, configuration, and operational procedures.

Requirements

Bachelor’s degree in Engineering, Information Systems, Computer Science, or related field.
7+ years of SAP PLM experience, including architecture and end -to -end implementation leadership.
Strong experience with SAP S/4HANA PLM, DMS, ECM, and Engineering Records.
Direct experience supporting PLM processes in a regulated medical device or pharmaceutical environment.
Knowledge of FDA QSR, 21 CFR Part 11 (electronic records/signatures), ISO 13485, and ISO 14971.
Experience with PLM -CAD integration tools (e.g., SAP ECTR).
Proven ability to lead cross -functional teams and drive alignment with business stakeholders.
Strong analytical and solution design skills
Excellent communication and stakeholder management
Ability to translate regulatory requirements into system capabilities
Strategic thinking with hands -on implementation ability
Detail -oriented with strong documentation and validation discipline

Nice To Haves

Experience with SAP EPPM, SAP MDG, or SAP Intelligent Product Design (IPD).
Familiarity with eQMS systems (e.g., MasterControl, ETQ, TrackWise) and MES platforms.
Experience with system validation (CSV) in a regulated environment.
Master’s degree in Engineering, IT, or Business.
SAP PLM or SAP Architecture certifications.

Responsibilities

Define and own the SAP PLM system architecture, roadmap, and standards across the enterprise.
Lead solution design for SAP PLM modules including: SAP PLM 7.x / SAP S/4HANA PLM, Engineering Records (ER), Engineering Change Management (ECM), Document Management System (DMS), Recipe/Specification Management (where relevant), Classification & Variant Configuration
Ensure integration of PLM with SAP modules such as PP, QM, MM, SD, EWM, and with external systems (CAD, MES, LIMS, eQMS).
Translate medical device product lifecycle requirements into SAP PLM processes, including: Design controls (per 21 CFR Part 820, ISO 13485), Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Risk management (ISO 14971), Traceability across requirements, changes, and documentation
Ensure SAP PLM aligns with FDA QSR and EU MDR documentation, audit, and quality compliance needs.
Act as the SME for SAP PLM and champion best practices for data governance, versioning, change management, and digital thread integration.
Lead configuration, functional design, and system enhancements.
Provide technical leadership to internal teams and external implementation partners.
Develop integration strategies with CAD (e.g., SolidWorks, Creo, AutoCAD), ALM, and document control systems.
Work with business teams to gather requirements, define user stories, and convert them into technical solutions.
Lead workshops, design sessions, and cross -functional meetings.
Provide guidance for testing (IQ/OQ/PQ), validation documentation, and change control under medical device regulations.
Ensure projects are delivered on time, within scope, and aligned with the enterprise architecture.
Provide Tier -3 support for SAP PLM and related integrations.
Identify opportunities for process optimization and automation (workflow, approvals, digital signatures).
Maintain documentation for system design, configuration, and operational procedures.