Reliability Engineer II

Reliability Engineer II (Through end of April 2026 // Mounds View, MN):

Note from the Manager: 100% on site

Top 3 Skills:

1. Reliability Engineering and Design Assurance testing, such as functional, stress, HALT/ALT, and accelerated life testing
2. Product Test Method Development
3. Product Test Method Validation and Design Verification support

Primary Responsibilities:

1. Setup and execution of test methods for Test Method Validation or Design Verification
2. Report writing and approval
3. Custom sample and/or fixture development

Target Years of Experience: 1-3 years of product testing experience

Duties:

• Navigates the complexity of government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union (EU) Medical Device Regulation (MDR), ISO 14971.
• Ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.
• Acts as a collaborative effective leader or team member in supporting quality disciplines, decisions, and practices.
• Develop and/or support the development of risk management architecture, support Design for Reliability and Manufacturability (DRM) targets, support design and phase reviews, and support design transfer.
• Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
• Develops overall operating criteria to ensure implementation of the quality program according to project, process and contract requirements and objectives, and ensures compliance of projects and related documents with requirements and standards.
• Reviews design, change specifications, and plans against contractual and/or process requirements.
• Reviews include applicable specifications, materials, tools, techniques, and methodologies.
• Provides or directs verification of device requirements, traceability, and testability.
• Recommends and implements design or test methods for achieving required levels of product reliability.
• Plans and leads test method validation of design verification methods. Responsible for design verification planning and execution. Responsible for verifying product and software performance meets design requirements.
• Utilizes statistical analysis tools to analyze data, such as Analysis of Variance (ANOVA), Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis and Test Method Validation (TMV). Completes reports.
• Completes risk management files of new design and updates to released products.
• Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.

Required Experience:

• Bachelor's Degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 1 years of work experience in Engineering and/or Quality
• Reliability Testing, Design Verification, and/or Test Method Validation
• Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team

Nice To Haves:

• 1-3 years of Medical Device industry experience
• Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR)
• Familiar with these standards: ISO 13485, ISO 14971, IEC 60601
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS