Sr. R&D Document Specialist

Position Summary

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.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.

Principal 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.

Education / Experience Requirements

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

Specialized Skills / Other Requirements

•    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

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The pay range for this position at commencement of employment is expected to be between $100,500- $150,800, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.