Design Assurance Engineer

MicroAire Surgical Instruments LLC

Charlottesville, VA, US
Not specified; not specified; competitive compensa...
Not specified (assumed onsite)
Bachelor's degree in mechanical or biomechanical engineering
Experience with verification and validation testing
Familiarity with ansi y14.5 drafting standards
MicroAire Surgical Instruments LLC is seeking a Design Assurance Engineer to join their team in Charlottesville, VA. The role focuses on ensuring medical device designs meet regulatory standards and user safety, providing an excellent opportunity for early-career engineers to gain hands-on experience in a regulated environment

Job Summary

  • This role plays a critical part in ensuring medical device designs meet requirements, comply with standards, and mitigate patient risk.
  • Candidates will contribute to verification and validation test plans, analyze data, and support root cause analysis within a regulated environment.
  • The company offers hands-on learning, exposure to the full product development lifecycle, and opportunities to grow within a global healthcare organization.

Matching Summary

Match Score: 75

MicroAire Surgical Instruments LLC is seeking a Design Assurance Engineer to join their team in Charlottesville, VA. The role focuses on ensuring medical device designs meet regulatory standards and user safety, providing an excellent opportunity for early-career engineers to gain hands-on experience in a regulated environment.

Salary

Not specified; Not specified; Competitive compensation, 401K with match, Medical/Dental/Vision, Vacation & Paid Holidays

Skills & Requirements

Must-have

  • Bachelor's degree in Mechanical or Biomechanical Engineering
  • Experience with verification and validation testing
  • Familiarity with ANSI Y14.5 drafting standards
  • Knowledge of risk management and usability engineering
  • Proficiency with SolidWorks for 3D modeling

Nice-to-have

  • Medical device industry internship experience
  • Understanding of corrosion and wear factors
  • Statistical concepts for sample size calculations
  • Collaboration with cross-functional teams
  • Strong written and verbal communication skills

Key Requirements

  • Bachelor's degree in Mechanical or Biomechanical Engineering
  • New graduates welcome to apply
  • No specific years of experience required but exposure desired

Work Rights

Not specified

Tailored Resume

Cover Letter