Biomedical Device Engineer: Sterilization & Compliance

Hufriedygroup; Town of Rush (NY); On-site; USD 90,000 - 140,000; Full time

Job summary

HuFriedyGroup is hiring a Biomed Engineer in the United States. The role focuses on designing and developing medical devices, including sterilization packaging and indicators, to meet FDA, ISO and CE regulatory standards.

You will work with scientists, regulatory, and manufacturing teams to ensure product quality and patient safety. Responsibilities include testing, protocol development, risk analysis, and documentation of designs and regulatory submissions.

Qualifications

• Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering or related field.
• Master’s degree in Biomedical/Mechanical/Electrical Engineering preferred.
• Proficiency with CAD software such as SolidWorks or AutoCAD.

Responsibilities

• Design and develop medical devices and sterilization-related products.
• Collaborate with scientists, regulatory, and manufacturing teams to meet standards.
• Create test protocols, validate and verify designs.
• Support risk management and post-market activities.
• Document designs, test results, and regulatory submissions.

Skills

Biomedical engineering

Mechanical engineering

Electrical engineering

CAD/design

Education

Bachelor's degree in Biomedical/Mechanical/Electrical Engineering

Master’s degree preferred

Tools

SolidWorks

AutoCAD

Job description

HuFriedyGroup is hiring a Biomed Engineer in the United States. The role focuses on designing and developing medical devices, including sterilization packaging and indicators, to meet FDA, ISO and CE regulatory standards.

You will work with scientists, regulatory, and manufacturing teams to ensure product quality and patient safety. Responsibilities include testing, protocol development, risk analysis, and documentation of designs and regulatory submissions.