Quality Engineer

Signifier Medical Technologies

Signifier Medical Technologies is a fast-growing medical technology company advancing clinically validated, non-invasive therapies for sleep-disordered breathing, including snoring and mild sleep apnea. We develop and deliver solutions such as eXciteOSA®, the first daytime therapy designed to target a root cause of sleep-disordered breathing, supporting patients and healthcare providers nationwide. Our focus is practical innovation—improving access to effective sleep health solutions today while building a durable platform for the future of care.

We are seeking a Quality Engineer that is responsible for performing detailed investigations of field‑returned medical devices, customer complaints, manufacturing rejects, and internal failures. This role ensures that issues are accurately diagnosed, properly documented, and communicated across Quality & Regulatory, Engineering, Manufacturing, and Supplier partners.

Job Summary

This position plays a critical role in maintaining device safety and reliability by identifying failure modes, supporting root‑cause analysis, providing data for risk management updates, and contributing to Customer Complaints and Corrective and Preventive Actions (CAPA). The Quality Engineer works within the Quality department and collaborates closely with R&D but maintains independent QA oversight.

Responsibilities

· Lead first‑level and intermediate‑level investigations of field‑returned devices, including visual inspection, functional testing, and replicate‑failure attempts.

· Document all findings thoroughly in accordance with ISO 13485, QMSR, CMDR, EU MDR and UK MDR.

· Identify whether failures are related to design, manufacturing, components, user error, environmental conditions, or wear/out‑of‑spec operation.

· Coordinate with customer service or field teams to obtain missing data, usage context, or device history.

· Coordinate with QA team and work on CAPAs and Customer Complaints as applicable.

· Perform detailed diagnostics to isolate failure modes (mechanical, electrical, firmware‑related, environmental).

· Support engineering team during second‑level root cause analysis by providing accurate failure data, logs, and samples.

· Participate in structured (Root Cause Analysis) RCA sessions such as 5-Why, Fishbone, Is/Is Not, and Fault Tree Analysis.

· Open and maintain Customer Complaints and Corrective and Preventive Action (CAPA) records as required.

· Ensure investigation outputs feed into Risk Management (ISO 14971), Technical File and Design History Files (DHF) when applicable.

· Provide trending data to management for inclusion in Management Review or product improvement initiatives.

· Develop and maintain standardized failure investigation procedures, checklists, and diagnostic workflows.

· Maintain investigation tools, fixtures, and test equipment.

· Collaborate with engineering to design new test setups or replicate field conditions for investigation accuracy.

· Work with R&D and to support deeper technical analyses.

· Provide timely summaries of investigation outcomes to Regulatory teams for complaint reporting or vigilance activities.

· Participate in supplier‑related issue resolution when failures trace back to supplier components.

· Record failure modes, trend all investigation results, suspected causes, and supporting evidence in the QMS.

· Produce investigation reports for internal teams, suppliers, or regulatory partners.

· Contribute to manufacturing and supplier performance metrics via data analysis and trend reporting.

Required Experience

· Working knowledge of ISO 13485, FDA QMSR, complaint handling processes, and root‑cause methodologies.

· Hands-on experience troubleshooting electro‑mechanical systems, embedded systems, and sensors.

· Exposure to ISO 13485, risk management (ISO 14971) and design controls.

· Familiarity with component analysis tools (oscilloscopes, multimeters, microscopes, ESD‑safe rework tools, environmental chambers).

· Experience using electronic QMS (eQMS) software.

Preferred Experience

· Strong analytical and diagnostic skills; ability to think like a forensic engineer.

· Excellent documentation quality; investigation records must be audit‑ready.

· Ability to work independently while coordinating across multiple teams.

· Comfortable handling ambiguous failures and systematically breaking them down.

· Strong communication skills for summarizing complex technical findings.

Qualifications

Bachelor’s degree in Engineering (Mechanical, Biomedical) or equivalent technical discipline with 3+ years of experience in biomedical engineering or related field; medical devices or other electronic devices in a regulated industry.

Why You’ll Love Working at Signifier Medical Technologies

• Mission-driven work that directly improves patients’ quality of life.
• Supportive, collaborative, family-oriented culture.
• Opportunity to shape and scale a rapidly growing team.
• Meaningful impact across the patient journey and the future of sleep health.
• Growth opportunities as our company expands nationally.

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Preferred)

Ability to Commute:

• Wake Forest, NC 27587 (Required)

Work Location: In person