Sr. R&D Document Specialist

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 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.

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.

Bachelors 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)

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

#LI-AD1

The pay range for this position at commencement of employment is expected to be between $100500- $150800 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.