Reliability & Design Quality Engineer - Medical Devices

ATR International; Minneapolis (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

ATR International seeks a Reliability & Design Quality Engineer to advance medical device technologies and introduce new products and therapies. You will develop, coordinate, and conduct technical reliability studies, DOE, risk analysis, and quality assurance standards to ensure medical device products meet performance and compliance requirements.

As an established individual contributor, you will work independently with supervision on moderately complex projects, collaborating with engineering

Qualifications

• Bachelor’s degree with a minimum of 2 years of relevant experience OR Master’s degree with 0+ years of relevant experience.
• Domain Expertise: Proven experience in Design Assurance, Design Quality, or Reliability Engineering.
• Industry Experience: Quality experience within the medical device industry.

Responsibilities

• Reliability Engineering & Analysis: Develop, coordinate, and conduct technical reliability studies and DOE constructs.
• Risk Management: Complete risk analysis studies for new designs and manufacturing processes; develop models to identify failure risks.
• Process Control & Testing: Recommend design/test methods and SPC procedures; specify environmental testing and sample sizes for valid data.
• Quality & Protocol Standards: Develop, modify, apply, and maintain quality standards and protocols for processing materials into products.
• Data & Corrective Action: Compile and analyze performance reports; investigate variables; ensure corrective measures meet reliability standards.
• Inspection & QA Testing: Design or specify inspection/testing mechanisms; conduct QA tests and statistical analyses.
• Cross-Functional Collaboration: Partner with engineering, manufacturing, and R&D to meet reliability objectives.
• Continuous Improvement: Propose design or formulation changes to improve system and process reliability; drive improvements.

Skills

Reliability engineering

Quality assurance

Design of experiments

Risk analysis

Education

Bachelor’s degree in related field

Master’s degree in related field

Job description

ATR International seeks a Reliability & Design Quality Engineer to advance medical device technologies and introduce new products and therapies. You will develop, coordinate, and conduct technical reliability studies, DOE, risk analysis, and quality assurance standards to ensure medical device products meet performance and compliance requirements.

As an established individual contributor, you will work independently with supervision on moderately complex projects, collaborating with engineering