Sr. R&D Document Specialist

Teleflex•Maple Grove, MN

6d•Onsite

About The Position

The Senior R&D Document Specialist serves as the subject matter expert for R&D document control, Product Lifecycle Management (PLM), and engineering change processes. This role ensures the accuracy, completeness, compliance, and timely release of product documentation throughout the product lifecycle. Working closely with Engineering, Quality, Regulatory, Manufacturing, and Supply Chain, the Senior Specialist provides technical leadership, drives process improvements, and supports successful product development and commercialization through effective management of engineering documentation within PLM, QMS, and ERP systems.

Requirements

Minimum of 5 years of experience in engineering document control, Product Lifecycle Management (PLM), engineering change management, or related functions within a regulated medical device environment.
Experience using PLM, ERP, and Quality Management Systems (Oracle Agile, SAP S/4HANA/MDG, Windchill, Arena, or equivalent)
Excellent written, verbal, and presentation skills with the ability to communicate effectively across all organizational levels
Highly detail-oriented with exceptional organizational and analytical skills.
Advanced knowledge of Quality Management Systems, engineering documentation, and compliance requirements within a regulated industry
Proven ability to influence without direct authority and effectively collaborate across cross-functional teams.
Autonomy and experience to effectively prioritize and execute projects/tasks with minimal oversight

Nice To Haves

Bachelor's degree in Engineering, Science, Technical Communications, or related discipline preferred.

Responsibilities

Serve as the R&D Subject Matter Expert (SME) for document control, engineering change management, and Product Lifecycle Management (PLM) processes.
Lead and facilitate engineering change orders (ECO/CO), ensuring documentation is complete, accurate, compliant, and progresses efficiently through review, approval, and release workflows.
Ensure engineering documentation complies with applicable FDA, ISO 13485, MDR, and internal Quality System requirements
Partner with cross-functional teams to develop, maintain, and release complete Design History File (DHF) documentation supporting new product development and sustaining engineering.
Ensure the integrity, accuracy, and consistency of engineering master data across PLM, ERP, and Quality Management Systems.
Identify and implement best practices in document control, and drive continuous improvements for R&D NPD projects.
Develop dashboards, reports, and performance metrics to monitor engineering change throughput, quality, cycle times, and process effectiveness to drive data-based decision making
Assist in monitoring process effectiveness, including the impact of changes, and recommend process improvements in PLM document control systems.
Provide expert support and consultation to Engineering, Quality, Regulatory, Manufacturing, Supply Chain, and other functional teams.
Lead strategic initiatives involving PLM, ERP integration, document control modernization, digital transformation, and process standardization
Mentor and train engineers and document specialists on document control processes, engineering change workflows, and system best practices.
Serve as the R&D functional lead for implementation, validation, testing, and deployment of new PLM, ERP, and document management functionality.
Participate in development and maintenance of document control procedures, work instructions, and business processes.
Serve as the primary escalation point for complex document control, engineering change, and PLM system issues.
Identify documentation risks that could impact product quality, regulatory compliance, or project timelines, and proactively implement corrective actions
Support audits, inspections, and regulatory submissions by providing documentation, traceability, and document control expertise.