Design Assurance Engineer

As a part of the global industrial organization Marmon Holdingswhich is backed by Berkshire Hathawayyoull be doing things that matter leading at every level and winning a better way. Were committed to making a positive impact on the world providing you with diverse learning and working opportunities and fostering a culture where everyones 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. MicroAireis 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 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 MicroAires 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 MicroAires devices can be used safely and effectively as intended.

This is an excellent opportunity for an earlycareer engineer to build handson experience in verification and validation risk management usability engineering and design controls within a regulated medical device environment.

What Youll 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 & CrossFunctional 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 Youll Bring

• Bachelors 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 problemsolving skills
• Clear written and verbal communication abilities
• Strong organization timemanagement and collaboration skills
• Proficiency with Microsoft Office and common engineering tools
• Ability to work independently and effectively within crossfunctional teams

Why MicroAire

At MicroAire youll contribute to innovative surgical technologies in a collaborative environment where quality and patient safety are paramount. We offer handson 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 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 and please be sure to include the title and the location of the position for which you are applying.