Biomedical Engineer

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Biomedical Engineer

Manufacturing Operations Full-Time Exempt Employee Professional Rush, NY, US

2 days ago Requisition ID: 1419

Salary Range: $75,000.00 To $85,000.00 Annually

About Company:

Join Our Team at HuFriedyGroup – Innovating Excellence in Dental Instrument Manufacturing

HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our 10,000-plus products, hand-crafted by highly skilled artisans, are known for their precision, performance, longevity, reliability, and quality. To help dental professionals be The Best in Practice, HuFriedyGroup provides a unique combination of world class products, value-added services, clinical education, and dental community platforms that result in superior clinician performance and enhanced safety for dental professionals and their patients. Working at HuFriedyGroup is so much more than a job, as every employee has a part in driving and supporting the organization’s inspirational vision to be a global force in advancing dental performance through Best-In-Practice dentistry that improves lives around the world.

Positioned within our Industrial/Life Sciences segment, the Biomedical Engineer will be responsible for the design, development, testing, and implementation of innovative processes and products. The role involves close collaboration with cross-functional teams, including scientists, regulatory, manufacturing engineers and other subject matter experts, to ensure our products meet industry standards and improve patient outcomes.

Duties:

• 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.

About Company:

Join Our Team at HuFriedyGroup – Innovating Excellence in Dental Instrument Manufacturing

HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our 10,000-plus products, hand-crafted by highly skilled artisans, are known for their precision, performance, longevity, reliability, and quality. To help dental professionals be The Best in Practice, HuFriedyGroup provides a unique combination of world class products, value-added services, clinical education, and dental community platforms that result in superior clinician performance and enhanced safety for dental professionals and their patients. Working at HuFriedyGroup is so much more than a job, as every employee has a part in driving and supporting the organization’s inspirational vision to be a global force in advancing dental performance through Best-In-Practice dentistry that improves lives around the world.

Biomed Engineer

Positioned within our Industrial/Life Sciences segment, the Biomedical Engineer will be responsible for the design, development, testing, and implementation of innovative processes and products. The role involves close collaboration with cross-functional teams, including scientists, regulatory, manufacturing engineers and other subject matter experts, to ensure our products meet industry standards and improve patient outcomes.

Duties:

• 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.

Requirements:

• 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.

Preferred Qualifications/Experience:

• 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.)

Specific Skills and/or Business Competencies

• Strong analytical and problem-solving skills.
• Excellent communication and teamwork abilities.

Equal Employment Opportunity & Accessibility Statement

HuFriedyGroup is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We prohibit discrimination and harassment of any kind based on race, color, religion, age, gender, national origin, disability status, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

If you require reasonable accommodations to apply for a position, participate in the recruitment process, or perform essential job functions, please contact us at 773-868-5534. We are committed to supporting you throughout your journey with HuFriedyGroup!