---
title: 'PLM & Quality Systems Specialist at Noctrix Health'
canonical: 'https://feeny.ai/job/plm-quality-systems-specialist-noctrix-health-pittsburgh-vgv3mdqcwg86'
type: 'job'
last_seen: '2026-11-06'
---

# PLM & Quality Systems Specialist at Noctrix Health

- **Company:** Noctrix Health
- **Location:** Pittsburgh, PA
- **Posted:** 2026-10-30
- **Last confirmed live:** 2026-11-06
- **Apply:** https://job-boards.greenhouse.io/noctrixhealth/jobs/5430428008

## Job description

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

## About Noctrix Health

## Company Overview
- **One-liner**: Noctrix Health develops clinically validated wearable neuromodulation devices as non-pharmaceutical alternatives for managing chronic neurological disorders, starting with Restless Legs Syndrome (RLS).
- **Entity Type**: Private (Acquired by ResMed in May 2026 for $340M)
- **Headquarters**: Pleasanton, California, United States
- **Founded**: 2018
- **Founders**: Jonathan Charlesworth (CSO), Justin Kelly (SVP, Product), Steve Lien (SVP, Patient Access), Shriram Raghunathan (CEO)

## Core Business
- **Primary industry/industries**: Medical Device Manufacturing, Neuromodulation, Wearable Therapeutics, Sleep Health
- **Target customers**: B2B (healthcare providers, sleep clinics, DMEs) and B2C (patients with Restless Legs Syndrome)
- **Mission or purpose statement**: To innovate the next generation of clinically-validated wearable therapeutics to address the unmet needs of millions of people living with chronic medical conditions.

## Products & Services
- **[Nidra® Therapy (TOMAC Therapy)]**: A prescription wearable device that delivers Tonic Motor Activation (TOMAC) therapy to treat Restless Legs Syndrome (RLS). It is a non-pharmaceutical, clinically validated alternative that uses neuromodulation to alleviate symptoms without disrupting sleep. The therapy has received favorable inclusion in the American Academy of Sleep Medicine (AASM) clinical practice guidelines and has dedicated CMS reimbursement codes.

## Market Standing
- **Valuation/Market Cap**: Acquired by ResMed for $340 million (announced May 6, 2026).
- **Key Metric**: Total funding raised was approximately $57M (per CB Insights) to $107.2M (per LinkedIn), with the most recent round being a Series C - II. Annual revenue is estimated at $2.5M (pre-acquisition).
- **Notable Investors/Partners**: ResMed (acquirer), OrbiMed, Treo Ventures, The Blue Venture Fund, Sandbox Industries, Bridge Bank.
- **Growth Signals**: Headcount grew 100% YoY to 110 employees. The company secured dedicated CMS reimbursement codes for Nidra therapy. The therapy was included in new AASM clinical practice guidelines for RLS. The company was acquired by ResMed for $340M in May 2026, signaling strong validation and a major growth trajectory.

## Competitive Advantages
- **First-to-market with a non-pharmaceutical wearable for RLS**: Nidra therapy is a clinically validated, drug-free alternative for a condition affecting ~7% of adults globally, offering a significant differentiator in a market dominated by pharmaceuticals.
- **Strong clinical and regulatory moat**: The therapy has been included in AASM clinical practice guidelines and has dedicated CMS reimbursement codes, creating high barriers to entry for competitors.
- **Backed by ResMed**: The $340M acquisition by the global leader in sleep health provides immense resources, distribution channels, and market credibility.

## Strategic Focus
- **Post-acquisition scaling**: Following the acquisition by ResMed, the primary focus is on rapidly scaling U.S. commercialization, expanding market access, and integrating Nidra therapy into ResMed's global sleep health portfolio.
- **Expanding indications**: While currently focused on RLS, the company's platform technology has potential for treating other chronic neurological disorders.
- **Building the commercial engine**: The company is actively hiring across sales, marketing, patient access, and engineering roles to support its growth.

## Why Work Here
- **Patient-centered mission**: The company is deeply mission-driven, with a culture that prioritizes improving patient lives. Employees describe a strong sense of purpose in delivering life-changing therapy.
- **High-growth environment**: With 100% YoY headcount growth, a recent $340M acquisition, and 50+ open roles, this is a fast-scaling company with significant career advancement opportunities.
- **Culture of transparency and problem-solving**: The company emphasizes core values like "embrace the unknown," "build trust through transparency," and "win as a team," fostering a collaborative and innovative environment.
- **Remote-friendly**: Many roles are listed as remote, including sales, patient access, and support positions, though some engineering and marketing roles are based in Pleasanton, CA, or Pittsburgh, PA.
- **Strong engineering and clinical culture**: The team is a mix of seasoned medical device experts, neuroscientists, and engineers from the consumer electronics world, offering a unique blend of high-tech and life-science work.

## Sources
1. [noctrixhealth.com](https://noctrixhealth.com/)
2. [noctrixhealth.com/careers](https://noctrixhealth.com/careers/)
3. [greenhouse.io](http://job-boards.greenhouse.io/noctrixhealth)
4. [linkedin.com](https://www.linkedin.com/company/noctrix-health)
5. [cbinsights.com](https://www.cbinsights.com/company/noctrix-health)

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