Design Assurance Engineer
Marmon Holdings, Inc., Charlottesville, VA, United States
Design Assurance Engineer page is loaded## Design Assurance Engineerlocations:
Charlottesville, VAtime type:
Full timeposted on:
Posted Todayjob requisition id:
JR0000042541MicroAire Surgical Instruments LLCAs a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.**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 Engineering**,
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.**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* 401K with company match* Medical/Dental/Vision* Vacation & Paid Holidays* Connection with Marmon Holdings companywide initiativesFollowing 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.Wherever you're at in your career, our people and resources will help you go further. As you grow your skills, you can also move up and around our 120+ companies.
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Charlottesville, VAtime type:
Full timeposted on:
Posted Todayjob requisition id:
JR0000042541MicroAire Surgical Instruments LLCAs a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.**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 Engineering**,
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.**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* 401K with company match* Medical/Dental/Vision* Vacation & Paid Holidays* Connection with Marmon Holdings companywide initiativesFollowing 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.Wherever you're at in your career, our people and resources will help you go further. As you grow your skills, you can also move up and around our 120+ companies.
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