Quality Engineer - Medical Device Manufacturer - JN-052026-7028718

Opportunity to have an impact on people's lives
Bonus Eligible!

About Our Client

My client is a medical device manufacturer focused on electro-mechanical production processes. They are rapidly expanding with the launch of a new product line, where you will play a key role in daily operations. The organization is ISO 13485 certified, and its products and services are distributed in nearly 50 countries. This role offers the opportunity to contribute to work that has a meaningful impact on people's lives.

Job Description

Conduct detailed evaluations of returned devices through inspection, functional testing, and operation of equipment
Reproduce reported issues by simulating real-world usage conditions, including edge cases and worst-case scenarios
Instrument systems to monitor performance, analyze signals, and isolate abnormal behavior
Convert customer complaints and observations into clear, testable hypotheses
Design and perform targeted experiments to replicate and validate reported failures
Diagnose issues across mechanical systems (e.g., fluid paths, seals, pressure interactions), electrical systems (e.g., power distribution, sensors, signal integrity), and embedded systems/software (e.g., logic triggers, alarms, system behavior)
Apply structured problem-solving techniques (e.g., 5 Whys, fishbone diagrams) alongside hands-on investigation
Generate and analyze test data to support findings and determine root causes
Identify recurring failure trends and link symptoms to underlying mechanisms
Define and recommend corrective actions based on verified root causes
Partner with R&D teams to implement design improvements and with Manufacturing to enhance processes
Ensure insights are integrated into risk management activities and ongoing product development

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

Bachelor's Degree (Engineering-related preferred)
3+ years of manufacturing experience within quality
Understanding of ISO 9001
Experience with electro-mechanical processes
Hands-on troubleshooting and investigation experience on electro-mechanical systems/components
Medical device experience is preferred
Understanding of ISO 14971 and UL 60601 is preferred
CQE certification is preferred
Six Sigma belt is preferred
Sponsorship is not provided