Quality Engineer - Device Investigation

Job Description

Job Description

Description:

Company Overview

Organ Recovery Systems is a leading medical technology company dedicated to improving outcomes for organ transplant patients. The company develops innovative preservation and perfusion systems that help maintain donor organs outside the body, increasing the number of viable transplants and saving lives worldwide. With a strong focus on engineering, innovation, and collaboration, Organ Recovery Systems works at the intersection of healthcare and technology to solve complex, real-world challenges.

POSITION SUMMARY:

The Quality Engineer – Device Investigation is responsible for hands-on investigation and failure detection of electro-mechanical medical devices in the field.

This role focuses on reproducing, diagnosing, and isolating product failures, using practical engineering techniques to determine true root causes. The engineer will work directly with returned devices, test setups, and system data to understand failure mechanisms across mechanical, electrical, and software domains.

The role requires strong technical troubleshooting capability and a bias toward physical problem-solving and system-level diagnostics, rather than reliance on documentation review alone.

PRIMARY FUNCTIONS :

1. Hands-on Failure Investigation

• Evaluate returned devices through direct inspection, testing, and operation of equipment
• Recreate reported issues by replicating use conditions and simulating edge or worst-case scenarios
• Instrument systems to monitor performance, probe signals and isolate abnormal behavior

2. Failure Detection & Reproduction

• Translate customer complaints and observations into testable hypotheses
• Design and execute targeted experiments to provoke and confirm failures
• Diagnose failures across:

-mechanical systems (fluid paths, seals, pressure)

-electrical systems (power, sensors, signal integrity)

-embedded/software behavior (logic triggers, alarms)

3. Root Cause Analysis and Problem Solving

• Apply structured methods (e.g., 5 Whys, fishbone) in combination with hands-on investigation
• Develop test evidence to support conclusions and identify root cause(s)
• Analyze complaint trends to identify recurring failure modes and connect symptoms to underlying mechanisms

4. Corrective Actions & Feedback Loop

· Define corrective actions based on verified failure mechanisms

· Collaborate with R&D (design fixes) and Manufacturing (process improvements)

- Ensure findings feed into risk management and design improvements

QUALIFICATIONS:

Education/Training/ Certifications/Licenses:

A. Bachelor’s degree in Engineering (Mechanical or Electrical preferred).

B. 3-8+ years experience in Electrical or Mechanical Engineering, or related service engineering, failure analysis or reliability engineering roles. Experience with medical device equipment preferred.

C. Certified Quality Engineering (CQE) or Six Sigma Black Belt (SSBB) preferred.

Experience:

A. Hands on troubleshooting with electro-mechanical systems

B. Ability to replicate failures and isolate faults

C. Demonstrated experience utilizing root cause analysis tools (5 Whys, Fishbone, fault tree, etc.)

Skills/Abilities :

A. Familiarity with diagnostic tools (multimeter, oscilloscope, sensors, etc.)

B. Strong technical writing skills for clear, objective, audit-defensible documentation.

C. Demonstrated ability to analyze data, identify trends, and communicate findings effectively.

D. Strong computer skills (Excel, Word, PowerPoint, MS-Project, Minitab)