Kannanware
Key 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), and 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 per
ISO 14971 , and traceability across requirements, changes, and documentation.
Ensure SAP PLM aligns with FDA QSR and EU MDR documentation, audit, and quality compliance needs.
Act as 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 (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 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.
Qualifications
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, 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.
Preferred
Experience with SAP EPPM, SAP MDG, or SAP Intelligent Product Design (IPD).
Familiarity with eQMS systems (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.
Key Competencies
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.
Additional Information
Seniority level: Mid‑Senior level.
Employment type: Full‑time.
Job function: Information Technology.
Industry: IT Services and IT Consulting.
Salary: $175,000.00–$225,000.00
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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), and 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 per
ISO 14971 , and traceability across requirements, changes, and documentation.
Ensure SAP PLM aligns with FDA QSR and EU MDR documentation, audit, and quality compliance needs.
Act as 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 (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 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.
Qualifications
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, 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.
Preferred
Experience with SAP EPPM, SAP MDG, or SAP Intelligent Product Design (IPD).
Familiarity with eQMS systems (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.
Key Competencies
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.
Additional Information
Seniority level: Mid‑Senior level.
Employment type: Full‑time.
Job function: Information Technology.
Industry: IT Services and IT Consulting.
Salary: $175,000.00–$225,000.00
#J-18808-Ljbffr