Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Be part of our mission to transform healthcare, improve lives, and drive meaningful change with Noctrix Health.
We are seeking an experienced and detail-oriented PLM & Quality Systems Specialist to own Product Lifecycle Management (PLM) and document control processes supporting Noctrix Health’s Product organization. This role will serve as a key subject-matter expert for PLM and eQMS processes, helping ensure the systems and workflows supporting product development, change management, design transfer, and sustaining activities are efficient, scalable, traceable, and compliant.
The ideal candidate brings hands-on experience administering PLM or eQMS platforms within an FDA- and ISO-regulated environment and is comfortable managing day-to-day document and change-control activities while also identifying and implementing process improvements. This individual will work cross-functionally with Engineering, Quality, Regulatory, Operations, Supply Chain, Finance, and Program Management to improve product data accuracy, configuration control, process efficiency, and quality-system usability.
This is a full-time, hybrid position based in our office in Oakmont, PA, with a minimum of three days onsite per week, or more depending on business needs.
Responsibilities
- Own and continuously improve Product Lifecycle Management and Product document-control processes, including workflows, templates, approval structures, configuration management, and change control
- Serve as the Product team’s PLM/eQMS subject-matter expert, supporting system administration, workflow configuration, troubleshooting, user adoption, and continuous improvement
- Develop, maintain, and improve QMS documentation supporting Product activities, including Design History Files (DHF), Bills of Materials (BOMs), SOPs, forms, templates, and related product records
- Ensure product records are accurate, complete, appropriately controlled, and maintained in accordance with company procedures and applicable regulatory requirements
- Manage document version control, review, approval, release, implementation, and archival activities
- Administer Document Change Order (DCO) and Engineering Change Order (ECO) processes, ensuring changes are appropriately documented, reviewed, approved, and implemented
- Configure and tailor PLM/eQMS workflows, document structures, approval processes, and system functionality to support Noctrix-specific product development and quality-system needs
- Evaluate DCO/ECO workflows and identify opportunities to simplify routing, reduce unnecessary approvals, improve cycle time, and strengthen compliance
- Support New Product Introduction (NPI), design transfer, product changes, and sustaining engineering activities through effective document release and configuration management
- Maintain end-to-end traceability and configuration control across requirements, design outputs, BOMs, risk management documentation, verification and validation records, change management, manufacturing documentation, and released product records
- Manage BOM configuration and product data to ensure clear and accurate communication of component, supplier, sourcing, and costing information
- Partner with Engineering, Operations, Supply Chain, and Finance to improve the accuracy, visibility, and usability of supplier and cost information within product BOMs
- Collaborate with Quality and Regulatory teams to ensure Product documentation and PLM processes align with QMS requirements and applicable regulatory expectations
- Establish and maintain mechanisms for tracking open document changes, upcoming releases, aging changes, bottlenecks, and overdue approvals
- Develop and maintain metrics and dashboards for document-control performance, change-order cycle time, approval aging, compliance, and overall process effectiveness
- Identify inefficiencies within PLM, document-control, and quality-system processes and implement scalable improvements that increase efficiency, traceability, and usability
- Evaluate and appropriately leverage automation and AI tools to improve process efficiency, data quality, and administrative workflows within a controlled environment
- Develop and maintain a prioritized roadmap for longer-term PLM/eQMS improvements, automation, and system optimization
- Support internal and external audits by ensuring Product documentation is complete, controlled, traceable, and readily accessible
- Support audit and inspection requests related to product records, design documentation, change control, and PLM/eQMS processes
- Provide guidance and training to Product and cross-functional users on PLM/eQMS processes, document-control requirements, and system best practices
- Maintain a high level of ownership and independence while managing multiple priorities within a dynamic, regulated product-development environment
Requirements
- 5+ years of relevant experience within an FDA- and/or ISO-regulated environment, including demonstrated ownership of document control, PLM, configuration management, or quality-system processes
- Bachelor’s degree in Engineering or a related technical field preferred; relevant PLM/eQMS and regulated-industry experience may be considered in lieu of a degree
- Hands-on experience administering and working within PLM or eQMS platforms such as Arena or equivalent systems
- Demonstrated experience configuring and tailoring PLM/eQMS workflows, document structures, approval processes, and change-control workflows
- Experience administering DCO and ECO processes within a regulated product-development environment
- Strong understanding of document control, version control, configuration management, and controlled product release processes
- Experience supporting NPI, design transfer, product changes, and sustaining engineering activities
- Experience managing BOMs, product configuration data, and associated product documentation
- Working knowledge of applicable medical device quality and regulatory requirements, including ISO 13485, 21 CFR Part 820, and 21 CFR Part 11
- Demonstrated experience identifying process inefficiencies and implementing scalable PLM, document-control, or quality-system improvements
- Strong documentation skills and proficiency with Microsoft Excel, Word, and PowerPoint
- Strong analytical and problem-solving skills with the ability to identify workflow bottlenecks and develop practical solutions
- Strong attention to detail and commitment to data integrity, traceability, and documentation accuracy
- Ability to work independently, manage multiple priorities, and adapt to changing business needs
- Strong interpersonal and communication skills with the ability to collaborate effectively across Engineering, Quality, Regulatory, Operations, Supply Chain, Finance, and Program Management
Preferred Qualifications
- Medical device industry experience, particularly with Class II devices
- Experience supporting Design History Files and other design-control documentation
- Experience with Arena PLM/eQMS
- Experience with BOM management, configuration control, supplier information, and product costing
- Experience establishing PLM/eQMS dashboards, metrics, and change-control performance reporting
- Experience supporting internal audits, external audits, or regulatory inspections
- Experience improving document-control or change-management processes within a high-growth organization
- Experience using automation or AI tools to improve process efficiency or data quality within an appropriately controlled environment
- Experience working within a startup, growth-stage, or rapidly evolving medical device organization
