Design Assurance Engineer

Marmon Holdings, Inc.•Charlottesville, VA

1d•Onsite

About The Position

This role plays a critical role within MicroAire’s New Product Development teams. As a Design Assurance Engineer (DAE), you will help ensure that medical device designs meet defined requirements, comply with applicable standards, and effectively mitigate patient and user risk. This role also supports Usability Engineering efforts to ensure MicroAire’s devices can be used safely and effectively as intended. This is an excellent opportunity for an early‑career engineer to build hands‑on experience in verification and validation, risk management, usability engineering, and design controls within a regulated medical device environment.

Requirements

Bachelor’s degree in Mechanical Engineering or Biomechanical Engineering
Experience with 2D drafting and 3D modeling (SolidWorks preferred)
Familiarity with ANSI Y14.5 drafting standards
Basic understanding of: Mechanical components and assemblies
Basic understanding of: Factors affecting reusable surgical instruments (corrosion, wear, thermal cycling)
Basic understanding of: Statistical concepts related to sample size calculations and data analysis
Strong technical, analytical, and problem‑solving skills
Clear written and verbal communication abilities
Strong organization, time‑management, and collaboration skills
Proficiency with Microsoft Office and common engineering tools
Ability to work independently and effectively within cross‑functional teams

Nice To Haves

Medical device industry experience/exposure desired (internships or academic work)
Exposure to product verification testing, risk management, and/or usability engineering

Responsibilities

Contribute to detailed verification and validation test plans supporting product requirements and risk control measures
Author test protocols and execute testing, coordinating with external partners as needed
Support the design and build of test fixtures
Analyze test data, investigate failures, and support root cause analysis
Document results through clear, compliant test reports and supporting justification memos
Collaborate with Electrical Engineering on product safety, EMC, and IEC 60601 compliance testing
Provide input to risk analyses, including identification of potential failure modes and controls
Act as a reviewer/approver for assigned Risk Management activities related to verification efforts
Contribute to usability engineering activities by evaluating user interactions and potential use-related risks
Serve as a reviewer/approver for assigned usability engineering efforts
Ensure design control activities meet regulatory, industry, and business requirements
Support Product Development Engineering tasks as needed (design, prototyping, modeling, and project support)
Partner with Regulatory Affairs in preparation and review of regulatory submissions (e.g., 510(k), PMA, Technical Files)