Biomedical Engineer – Medical Devices & Sterility

Hufriedygroup

West Henrietta (NY)

On-site

USD 75,000 - 85,000

Full time

4 days ago

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Job summary

HuFriedyGroup is seeking a Biomedical Engineer in Rush, NY to design, develop, test, and implement innovative medical devices and sterility assurance products. You will collaborate with scientists, regulatory, and manufacturing teams to meet industry standards and improve patient outcomes.

The role requires a Bachelor's in biomedical/related field, CAD proficiency, and knowledge of FDA/ISO standards. Join a leader in dental instrumentation and infection prevention products with a strong emphasis

Qualifications

Bachelor’s degree in Biomedical/Mechanical/Electrical engineering.
Knowledge of FDA 21 CFR Part 820, ISO 13485, and related sterility standards.
Experience in medical device design and/or development.
Proficiency in CAD software 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.
Troubleshoot design and production issues to optimize processes and manufacturability.
Document designs, protocols, test results, and regulatory submissions.
Assist in risk management, including hazard analysis and FMEA.
Participate in quality assurance and compliance initiatives.