Associate Failure Analysis Engineer (Medical Devices)

Location: Waalwijk, Netherlands

Company

hirify.global is a medical device company developing the Omnipod platform for insulin delivery and other subcutaneous drug-delivery applications.

What you will do

• Conduct post-market product testing, failure analysis, investigation triage, and deep-dive investigations.
• Develop failure hypotheses, troubleshoot new failure modes, and perform root cause analysis.
• Maintain quality records supporting training, internal audits, NCRs, CAPAs, and the Quality System.
• Review Lot Acceptance records and DHRs, collect quality data, and create trend charts.
• Support FDA and ISO 13485 inspections by gathering relevant information.
• Evaluate process flows and engineering controls using Lean Six Sigma to improve safety and efficiency.

Requirements

• HBO or bachelor’s degree in engineering or a scientific discipline, including biomedical, industrial, mechanical, electronics, or manufacturing engineering, or equivalent experience.
• Proficiency with Microsoft Office, especially Excel.
• Electrical and mechanical engineering background.
• Strong verbal communication, technical writing, and record-keeping skills.
• Ability to operate basic hand tools and meet the physical requirements of the role, including occasional handling of loads up to 50 lb / 23 kg.

Nice to have

• Approximately two years of experience in a quality-related function.
• Experience with QSR, ISO 13485, Six Sigma, Lean, SPC, or ASQ process controls.
• Experience in a regulated medical device, biohazard, or laboratory environment.
• Experience creating and analyzing charts in Excel.

Culture & Benefits

• Full-time role within the Quality Department.
• Hands-on, cross-functional engineering work supporting regulated medical devices.
• Work involves approximately 70% sitting and 30% standing.
• Frequent lifting of loads under 5 lb / 2.3 kg and occasional pushing or pulling of loads up to 50 lb / 23 kg.