Job Title:  Solidworks/PDM Administrator

Job Summary:

We are seeking a detail-oriented and experienced Enterprise PDM Administrator to manage and optimize our Product Data Management (PDM) system in a regulated medical device environment. This role is essential in supporting our product development lifecycle, ensuring data integrity, and maintaining compliance with FDA and ISO standards.

Key Responsibilities:

•    PDM System Administration:
•    Work closely with IT and third parties to design, develop, and implement the enterprise PDM system.
•    Administer and maintain the enterprise PDM system (e.g., SOLIDWORKS PDM Professional).
•    Configure workflows, data cards, templates, and user/group permissions tailored to medical device development.
•    Ensure system uptime, performance, and data integrity in collaboration with IT and Quality teams.
•    Regulatory Compliance & Documentation:
•    Ensure PDM processes align with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations.
•    Maintain audit trails, electronic records, and document control procedures.
•    Support internal and external audits by providing accurate and timely data.
•    Cross-Functional Collaboration:
•    Work closely with all stakeholders to ensure that all requirements are met, that the system works well with all tools it interfaces with across all sites impacted, and that the system facilitates efficient project management aligned to our phase gate process and provides robust controls and tracking and management for Engineering Change Notice (ECN) management.
•    Work closely with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing to support product lifecycle management.
•    Facilitate integration between PDM and ERP/PLM systems to ensure traceability and data consistency.
•    User Support & Training:
•    Provide technical support and training to engineering and quality teams.
•    Develop and maintain SOPs, user guides, and training materials.
•    Act as the subject matter expert for PDM-related initiatives.
•    System Enhancements & Upgrades:
•    Plan and execute system upgrades, patches, and enhancements.
•    Evaluate and implement new features to improve usability and compliance.

Qualifications:

•    Bachelor’s degree in Engineering, Information Systems, or related field.
•    5+ years of experience administering enterprise-level PDM systems in a regulated industry.
•    Strong knowledge of SOLIDWORKS PDM Professional or equivalent.
•    Familiarity with FDA, ISO, and other regulatory requirements for medical devices.
•    Proficiency in SQL Server, Windows Server, and Active Directory.

Preferred Skills:

•    Experience with ERP/PLM integration (e.g., SAP, Oracle Agile).
•    Understanding of Design History Files (DHF), Device Master Records (DMR), and Change Control processes.
•    Experience with scripting or automation tools (e.g., PowerShell, PDM Dispatch).
•    Familiarity with CAD tools (e.g., SOLIDWORKS, AutoCAD).