Biomedical Engineer — Sterility & Medical Device Design

Hu-Friedy Mfg. Co., LLC; Town of Rush (NY); On-site; USD 75,000 - 85,000; Full time

Job summary

HuFriedyGroup is seeking a Biomedical Engineer in Rush, NY to design and develop medical devices, including sterilization packaging and indicators, with emphasis on regulatory compliance and cross-functional collaboration.

The role involves testing, validation, verification, and post-market support, aiming to improve patient outcomes and manufacturing efficiency. Strong CAD skills and regulatory knowledge are essential.

Qualifications

• Bachelor’s degree in Biomedical, Mechanical, Electrical engineering or related field.
• Knowledge of regulatory requirements such as FDA 21 CFR Part 820, ISO 13485 and sterility standards.
• Experience in medical device design and/or development.
• Proficiency in CAD software (SolidWorks, AutoCAD) for device modeling.

Responsibilities

• Design and develop medical devices, including sterilization packaging and indicators, ensuring regulatory compliance.
• Assist in research on new sterilization modalities and test systems.
• Develop and execute test protocols, including validation and verification.
• Work cross-functionally to integrate sterility assurance products and processes.
• Provide technical support during product development, manufacturing and post-market surveillance.
• Document designs, protocols, test results, and regulatory submissions.
• Assist in risk management processes, including hazard analysis and failure mode analysis.
• Participate in quality assurance and compliance initiatives to meet safety and effectiveness standards.

Skills

Analytical skills

Communication

Teamwork

Problem solving

Regulatory knowledge

Education

Bachelor's degree in Biomedical Engineering

Master's degree in Biomedical Engineering

Tools

SolidWorks

AutoCAD

Job description

HuFriedyGroup is seeking a Biomedical Engineer in Rush, NY to design and develop medical devices, including sterilization packaging and indicators, with emphasis on regulatory compliance and cross-functional collaboration.

The role involves testing, validation, verification, and post-market support, aiming to improve patient outcomes and manufacturing efficiency. Strong CAD skills and regulatory knowledge are essential.