Design Assurance Engineer
MicroAire Surgical Instruments, Charlottesville, VA, United States
MicroAire Surgical Instruments LLC
As part of the global industrial organization Marmon Holdings, backed by Berkshire Hathaway, MicroAire Surgical Instruments LLC plays a critical role in medical device development.
MicroAire, Who We Are
MicroAire Surgical Instruments (Charlottesville, VA) is a wholly‑owned subsidiary and one of five companies within the Medical Group of Marmon Holdings, a Berkshire Hathaway company. MicroAire is a mid‑sized medical device solutions company with a 45‑year legacy of quality and innovation. With well‑recognized brands, the company is uniquely positioned as a leader in specialty markets, including minimally invasive medical devices and equipment for aesthetics/reconstruction, endoscopic soft tissue release, and orthopedic accessories. MicroAire designs, manufactures, and markets cutting‑edge medical devices that empower surgeons to push the boundaries of surgical precision, delivering safe, efficient, and high‑quality patient outcomes.
About the Role
We are seeking a Design Assurance Engineer. The 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.
What You’ll Do
Verification & Validation
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
Risk Management
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
Usability Engineering
Contribute to usability engineering activities by evaluating user interactions and potential use‑related risks
Serve as a reviewer/approver for assigned usability engineering efforts
Design & Cross‑Functional Support
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)
What You’ll Bring
Bachelor’s degree in Mechanical Engineering or Biomechanical Engineering (new grads welcome to apply)
Medical device industry experience/exposure desired (internships or academic work)
Exposure to product verification testing, risk management, and/or usability engineering
Experience with 2D drafting and 3D modeling (SolidWorks preferred)
Familiarity with ANSI Y14.5 drafting standards
Basic understanding of:
Mechanical components and assemblies
Factors affecting reusable surgical instruments (corrosion, wear, thermal cycling)
Statistical concepts related to sample size calculations and data analysis
Skills For Success
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
Why MicroAire
At MicroAire, you’ll contribute to innovative surgical technologies in a collaborative environment where quality and patient safety are paramount. We offer hands‑on learning, exposure to the full product development lifecycle, and the opportunity to grow your career within a global healthcare organization.
Our Benefits
Competitive compensation
401(k) with company match
Medical/Dental/Vision
Vacation & Paid Holidays
Connection with Marmon Holdings companywide initiatives
Following receipt of a conditional offer of employment, candidates will be required to complete additional job‑related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.
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As part of the global industrial organization Marmon Holdings, backed by Berkshire Hathaway, MicroAire Surgical Instruments LLC plays a critical role in medical device development.
MicroAire, Who We Are
MicroAire Surgical Instruments (Charlottesville, VA) is a wholly‑owned subsidiary and one of five companies within the Medical Group of Marmon Holdings, a Berkshire Hathaway company. MicroAire is a mid‑sized medical device solutions company with a 45‑year legacy of quality and innovation. With well‑recognized brands, the company is uniquely positioned as a leader in specialty markets, including minimally invasive medical devices and equipment for aesthetics/reconstruction, endoscopic soft tissue release, and orthopedic accessories. MicroAire designs, manufactures, and markets cutting‑edge medical devices that empower surgeons to push the boundaries of surgical precision, delivering safe, efficient, and high‑quality patient outcomes.
About the Role
We are seeking a Design Assurance Engineer. The 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.
What You’ll Do
Verification & Validation
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
Risk Management
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
Usability Engineering
Contribute to usability engineering activities by evaluating user interactions and potential use‑related risks
Serve as a reviewer/approver for assigned usability engineering efforts
Design & Cross‑Functional Support
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)
What You’ll Bring
Bachelor’s degree in Mechanical Engineering or Biomechanical Engineering (new grads welcome to apply)
Medical device industry experience/exposure desired (internships or academic work)
Exposure to product verification testing, risk management, and/or usability engineering
Experience with 2D drafting and 3D modeling (SolidWorks preferred)
Familiarity with ANSI Y14.5 drafting standards
Basic understanding of:
Mechanical components and assemblies
Factors affecting reusable surgical instruments (corrosion, wear, thermal cycling)
Statistical concepts related to sample size calculations and data analysis
Skills For Success
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
Why MicroAire
At MicroAire, you’ll contribute to innovative surgical technologies in a collaborative environment where quality and patient safety are paramount. We offer hands‑on learning, exposure to the full product development lifecycle, and the opportunity to grow your career within a global healthcare organization.
Our Benefits
Competitive compensation
401(k) with company match
Medical/Dental/Vision
Vacation & Paid Holidays
Connection with Marmon Holdings companywide initiatives
Following receipt of a conditional offer of employment, candidates will be required to complete additional job‑related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.
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