Design Quality Engineer

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

We are seeking a Reliability & Design Quality Engineer to join our team as a Technical Specialist. In this role, you will advance existing medical device technologies and introduce new products and therapies. You will be responsible for developing, coordinating, and conducting technical reliability studies, design of experiments (DOE), risk analysis, and quality assurance standards to ensure all medical device products meet rigorous performance and compliance requirements.

As an established individual contributor, you will work independently with general supervision on moderately complex projects, collaborate closely with cross-functional engineering and manufacturing teams, and help ensure project milestones are achieved on time and to standard.

Core Responsibilities

Reliability Engineering & Analysis: Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.

Risk Management: Complete risk analysis studies for new designs and manufacturing processes. Develop mathematical models to identify units, batches, or processes posing excessive failure risks.

Process Control & Testing: Recommend design/test methods and statistical process control procedures to achieve required product reliability. Specify environmental testing and minimum sample sizes for statistically valid data.

Quality & Protocol Standards: Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.

Data & Corrective Action: Compile and analyze performance reports and process control statistics; investigate relevant variables affecting product and processes. Ensure corrective measures meet acceptable reliability standards and maintain compliant documentation.

Inspection & QA Testing: Design or specify inspection and testing mechanisms and equipment. Conduct quality assurance tests and perform statistical analyses to assess costs and determine responsibility for non-conforming materials or products.

Cross-Functional Collaboration: Partner with engineering, manufacturing, and R&D functions to establish quality standards and achieve company, customer, and regulatory agency reliability objectives.

Continuous Improvement: Propose design or formulation changes to improve system and process reliability. Recommend enhancements to systems and processes to solve technical problems.

Mentorship: Provide guidance and support to entry-level professionals and technical support team members.

Role Characteristics (Technical Specialist Stream)

Autonomy: Established individual contributor working independently with general supervision on larger, moderately complex assignments.

Organizational Impact: Sets individual objectives to align with broader project goals. Contributes directly to completing key project milestones.

Innovation & Complexity: Solves general engineering and quality problems using a broad understanding of related job areas. Proactively recommends process improvements.

Communication: Communicates regularly with internal cross-functional contacts to share status, gather input, and support decision-making.

Qualifications & Requirements

Must Have

Education & Experience:

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: General quality experience within the medical device industry.

Nice to Have

Lean / Six Sigma: Practical experience or certification in Lean or Six Sigma methodologies.

Project & Self-Management: Demonstrated self-driven, independent ability to engage cross-functional teams and manage multiple project workloads concurrently.