Staff Engineer, R&D

3 weeks ago


Andover, Massachusetts, United States embecta Full time
About the Role

As a Staff Engineer, R&D - Verification and Validation at embecta, you will be responsible for leading the design verification and validation of electromechanical medical devices. This role requires a strong technical background in electrical and mechanical systems, as well as experience with regulatory standards such as IEC 60601 and ISO 14971.

You will work closely with the R&D team to ensure that product requirements are relevant, testable, and measurable. Your responsibilities will include defining and executing testing regimens, developing and executing product reliability test plans, and implementing Design for Six Sigma (DFSS) methodology.

This is an excellent opportunity to join a global diabetes care company that is committed to empowering people with diabetes to live their best life through innovative solutions and partnerships.

Key Responsibilities
  • Collaborate with the R&D team to ensure product requirements are relevant, testable, and measurable
  • Define and execute testing regimens to demonstrate compliance with IEC 60601 for mechanical safety/essential performance
  • Develop and execute product reliability test plans for both durable and disposable medical devices
  • Implement DFSS methodology to improve design decisions and reduce design iteration cycle times
Requirements
  • Bachelor's degree in Mechanical Engineering, Electrical Engineering, Systems Engineering, Biomedical Engineering, or related field
  • 10+ years of professional experience leading or supporting product development projects, including electrical and mechanical systems
  • 5+ years of experience with leading or executing Design Verification of disposable electromechanical medical devices

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