Biomedical Engineer

HuFriedyGroup manufactures dental instruments and infection prevention products. The Biomedical Engineer designs, develops, tests, and implements medical devices and processes, collaborating with cross-functional teams to meet regulatory standards and improve patient outcomes.

Responsibilities

• Design and develop medical devices, to include sterilization packaging, Biological and Chemical Indicators, as well as other technical products ensuring compliance with regulatory standards (FDA, ISO, CE, etc.)
• Assist in conducting research on new and emerging sterilization modalities and test systems
• Develop and execute test protocols, including validation and verification processes
• Work cross-functionally and ensure seamless integration of sterility assurance products and processes
• Provide technical support during product development, manufacturing and post-market surveillance
• Troubleshoot design and production issues to optimize processes, performance, and manufacturability
• 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
• Other responsibilities designated by your manager

Preferred

• 3 years of professional experience in addition to education
• Master's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field
• Familiarity with programming languages (e.g., MATLAB, Python, C++) is a plus
• Experience within a manufacturing environment
• Certification from a professional engineering body (e.g. PE, CQE, etc.)
• 3+ Years Professional Experience
• Master’s Degree in Engineering
• MATLAB
• Python
• C++
• Manufacturing Experience
• Professional Engineering Certification
• PE Certification
• CQE Certification

Company

• Dental instrument manufacturing and infection prevention workflows
• Chicago, Illinois, USA
• https://www.hufriedygroup.com/
• Founded in 1908
• 1001-5000 employees

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field
• Knowledge of regulatory requirements, such as FDA 21 CFR Part 820, ISO 13485, and other sterility assurance related standards
• Experience in medical device design and/or development
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD) for device modeling
• Strong analytical and problem-solving skills
• Excellent communication and teamwork abilities
• 3 years of professional experience in addition to education
• Master's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field
• Familiarity with programming languages (e.g., MATLAB, Python, C++) is a plus
• Experience within a manufacturing environment
• Certification from a professional engineering body (e.g. PE, CQE, etc.)

Required skills

• AutoCAD, C++, Certified Quality Engineer (CQE), FDA 21 CFR Part 820, ISO 13485, MATLAB, Manufacturing, Medical Device Design and Development, Professional Engineer (PE) Certification, Python, SolidWorks

Preferred skills

• (1), (2), (3), *2026, 2021, 2024, 2024-04-11, 3 years of professional experience in addition to education, Accounting and Finance, Acquired, Andrew Xilas, Chicago, Illinois, USA, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Engineering and Development, Experience within a manufacturing environment, H1B Sponsorship, HuFriedyGroup To Acquire Mectron’s Dental Business, Late Stage, Leadership Team, Legal and Compliance, Product Management, Pulse 2.0, Recent News, Represents job field similar to this job, Retired, Total Funding, Trends of Total Sponsorships, https://www.hufriedygroup.com, unknown

Experience

• 3+ years