---
title: 'Senior Quality Engineer at Noctrix Health'
canonical: 'https://feeny.ai/job/senior-quality-engineer-noctrix-health-pleasanton-hdys93mj5sgm'
type: 'job'
last_seen: '2026-09-11'
---

# Senior Quality Engineer at Noctrix Health

- **Company:** Noctrix Health
- **Location:** Pleasanton, CA
- **Posted:** 2026-08-12
- **Last confirmed live:** 2026-09-11
- **Apply:** https://job-boards.greenhouse.io/noctrixhealth/jobs/5387901008

## 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). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology.

We are seeking an experienced Senior Quality Engineer to provide Quality Engineering leadership across new product development (NPD), sustaining product changes, and related manufacturing updates throughout the product lifecycle. This individual will serve as a Design Control subject matter expert (SME), partnering closely with cross-functional teams to ensure product development and change activities are executed in accordance with Noctrix procedures, applicable regulatory requirements, and industry best practices.

The Senior Quality Engineer will work closely with Regulatory Affairs, Clinical Affairs, Engineering, Operations, Manufacturing, project leads, contract manufacturers, suppliers, and external partners to guide design control activities, assess product changes, support verification and validation, integrate risk management, and lead Quality Engineering activities associated with manufacturing implementation. This role will also identify process roadblocks and opportunities to improve efficiency while maintaining compliance.

This position reports to the Director, Quality.

This is a full-time, hybrid position that is located at our Pleasanton headquarters.

Responsibilities:

- Serve as the Design Control subject matter expert and advise product teams on the application of Noctrix SOPs, applicable regulatory requirements, and design control best practices
- Act as the lead Quality representative for new product development and sustaining product changes involving hardware, firmware, software, labeling, components, suppliers, and related manufacturing updates
- Guide project teams through design planning, design inputs, design outputs, design reviews, design verification, design validation, design transfer, design changes, traceability, and risk management activities
- Review proposed product changes and advise teams on the appropriate design control, risk management, verification, validation, and documentation requirements
- Participate in project planning, design reviews, change reviews, and cross-functional technical discussions as the Quality representative
- Provide Quality Engineering guidance on verification and validation strategies, protocols, reports, acceptance criteria, traceability, risk assessments, and change implementation plans
- Lead Quality Engineering activities associated with manufacturing updates resulting from new product development and sustaining product changes
- Coordinate with Engineering, Operations, Manufacturing, contract manufacturers, suppliers, and external partners to ensure product changes are implemented effectively and compliantly
- Support supplier, component, and manufacturing changes that may impact product design, safety, performance, regulatory requirements, or manufacturing implementation
- Support CAPA and nonconformance activities, including investigation planning, root cause analysis, corrective action development, implementation, and effectiveness evaluation
- Own or support risk management activities and documentation for Class II or higher medical devices
- Review and approve design control, verification and validation, engineering change, risk management, and manufacturing implementation documentation
- Identify process roadblocks, compliance risks, unclear requirements, and inefficiencies affecting NPD, sustaining activities, and product change implementation
- Recommend and support practical improvements to design control, change management, risk management, verification and validation, and product development processes
- Serve as a Design Control SME during internal audits, external audits, certification audits, regulatory inspections, and Quality System readiness activities
- Provide technical guidance and mentorship to Quality personnel and cross-functional teams
- Promote consistent application of Design Control and Quality Engineering best practices across the organization

Requirements:

- Bachelor’s degree or higher in Engineering, Life Sciences, Quality, or a related technical discipline
- Minimum of 6 years of Quality Engineering experience within the medical device industry
- Significant experience supporting new product development and sustaining product changes
- Strong working knowledge of FDA Design Control and Quality System requirements, ISO 13485, ISO 14971, risk management, verification and validation, design transfer, and change control
- Demonstrated experience serving as a Design Control SME and advising cross-functional teams on regulatory requirements, company procedures, documentation expectations, and best practices
- Experience supporting medical device development and product changes involving hardware, firmware, software, labeling, components, suppliers, and manufacturing updates
- Experience owning or managing risk management documentation for Class II or higher medical devices
- Experience reviewing or approving Design Control, verification and validation, engineering change, and manufacturing implementation documentation
- Experience supporting Design Transfer and manufacturing implementation activities
- Experience leading or supporting CAPA and nonconformance investigations, root cause analysis, corrective actions, and effectiveness evaluations
- Strong understanding of the relationship between product risk, design controls, manufacturing changes, and regulatory compliance
- Strong analytical and problem-solving skills with the ability to identify compliance risks and recommend practical solutions
- Excellent technical writing, documentation, facilitation, and communication skills
- Strong organizational skills with the ability to independently manage multiple complex priorities
- Demonstrated ability to influence and guide cross-functional teams without direct authority

Preferred Qualifications:

- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar professional certification
- Experience with therapeutic wearable, connected medical device, or electro-mechanical medical device products
- Experience supporting software and firmware development within a medical device Design Control environment
- Experience working directly with contract manufacturers and external development partners
- Experience supporting FDA inspections, ISO 13485 certification audits, or other regulatory inspections
- Experience with supplier quality and component qualification activities
- Experience mentoring Quality Engineers or serving as a technical leader within a Quality organization
- Experience working within a high-growth medical device organization

Compensation:

- Base Pay: $150,000–$180,000 per year
- Annual Bonus Eligibility

## 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)

## Other roles at Noctrix Health

- [Territory Sales Manager – Georgia](https://feeny.ai/job/territory-sales-manager-georgia-noctrix-health-remote-bbsvb9hxhtbp)
- [Territory Sales Manager – Southern California](https://feeny.ai/job/territory-sales-manager-southern-california-noctrix-health-remote-6wpp7jpg860w)
- [Staff Accountant](https://feeny.ai/job/staff-accountant-noctrix-health-pleasanton-anhkzmksr5nk) — Pleasanton, CA
- [Manager, Regulatory Affairs](https://feeny.ai/job/manager-regulatory-affairs-noctrix-health-pleasanton-rww4jfgpsbbq) — Pleasanton, CA
- [Director, Clinical Affairs](https://feeny.ai/job/director-clinical-affairs-noctrix-health-pleasanton-d2z573r6sg9t) — Pleasanton, CA
- [Document Control & Quality Systems Administrator](https://feeny.ai/job/document-control-quality-systems-administrator-noctrix-health-pleasanton-sk3hnc4decz3) — Pleasanton, CA
- [Clinical Research Engineer](https://feeny.ai/job/clinical-research-engineer-noctrix-health-pleasanton-8a3wadsm94sk) — Pleasanton, CA
- [Patient Access Appeals Case Manager](https://feeny.ai/job/patient-access-appeals-case-manager-noctrix-health-remote-zhezztk3yg44)
- [Patient Access Case Manager](https://feeny.ai/job/patient-access-case-manager-noctrix-health-remote-ed8qk3d71rek)
- [Head of Marketing](https://feeny.ai/job/head-of-marketing-noctrix-health-pleasanton-5etv0s0qq434) — Pleasanton, CA