Oracle Fusion PLM Systems Analyst - Medical Devices

ATEC Spine, Inc.; Carlsbad (CA); Presencial; USD 110.000 - 125.000; Jornada completa

Descripción de la vacante

Alphatec Spine, Inc. seeks a PLM Analyst to support, configure, and optimize Oracle Fusion Cloud PLM in a regulated medical device environment. You will ensure integration with SAP S/4HANA, NiceLabel, and Cornerstone while upholding FDA, ISO 13485, and QMS requirements.

You will manage change workflows, documentation, validation, and audits, and support NPI/NPD as well as sustaining engineering activities. Strong cross-functional collaboration is essential.

Formación

• Bachelor’s degree in Engineering, Information Systems, Quality, or related field.
• 5–8 years of experience with Oracle Fusion Cloud PLM; Oracle Agile PLM preferred.
• Experience with QMS processes in a regulated medical device environment.
• Experience with SAP S/4HANA integration with PLM systems.
• Knowledge of FDA 21 CFR 820 and ISO 13485 regulations.
• Hands-on change control, document management, and BOMs.
• Experience with NiceLabel and label lifecycle management.
• Experience in the Medical Device Industry
• Experience with Cornerstone LMS integrations
• Experience with validation documentation
• Familiarity with SAP MM, PP, QM, SD modules
• Audits and regulatory inspections experience
• Strong analytical and problem-solving skills
• Excellent cross-functional communication
• Attention to detail and compliance mindset

Responsabilidades

• Serve as the primary administrator and SME for Oracle Fusion Cloud PLM.
• Configure workflows, attributes, user roles, permissions, and lifecycle states.
• Maintain product structures, BOMs, specifications, drawings, and metadata.
• Support system upgrades, enhancements, and quarterly Fusion Cloud releases.
• Manage ECO, MCO, CR, Deviations, and other change workflows.
• Ensure routing, approvals, and traceability of changes.
• Maintain DHF, DMR, and technical documentation within PLM.
• Support NPI/NPD and sustaining engineering activities.
• Support QMS processes managed within PLM or integrated systems.
• Support CSV activities (IQ/OQ/PQ, evidence, traceability).
• Participate in audits related to Fusion PLM and IT systems.
• Support PLM integrations with SAP and other systems.
• Coordinate issue resolution with SAP, middleware, and integration teams.
• Validate data consistency across systems.
• Provide Tier 2/3 support for PLM users.
• Create and maintain SOPs, work instructions, and training materials.
• Train users on PLM workflows and compliance requirements.
• Support access management and role design with IT Security.
• Identify opportunities to streamline PLM and QMS processes.
• Gather, analyze, and document business requirements with stakeholders.
• Translate business needs into PLM requirements.

Conocimientos

Oracle Fusion PLM

SAP S/4HANA integration

QMS compliance

FDA 21 CFR 820

ISO 13485

Change control

Document management

BOMs management

Audits & inspections

Cross-functional communication

Data traceability

Validation documentation

Educación

Bachelor’s degree in Engineering, Information Systems, Quality, or related field

4+ year Bachelor Degree or equivalent

Herramientas

NiceLabel

Cornerstone LMS

Descripción del empleo

Alphatec Spine, Inc. seeks a PLM Analyst to support, configure, and optimize Oracle Fusion Cloud PLM in a regulated medical device environment. You will ensure integration with SAP S/4HANA, NiceLabel, and Cornerstone while upholding FDA, ISO 13485, and QMS requirements.

You will manage change workflows, documentation, validation, and audits, and support NPI/NPD as well as sustaining engineering activities. Strong cross-functional collaboration is essential.