Biomedical Engineer
About The Position
Positioned within HuFriedyGroup’s Industrial/Life Sciences segment, the Biomedical Engineer designs, develops, tests, and implements innovative processes and products. The role collaborates with scientists, regulatory personnel, manufacturing engineers, and other subject matter experts to ensure products meet industry standards and improve patient outcomes. The engineer works on medical devices and sterility assurance products, including sterilization packaging and biological and chemical indicators. Responsibilities span research, design and development, testing and validation, manufacturing support, regulatory documentation, risk management, and quality assurance. The position may also include other responsibilities designated by the 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, such as SolidWorks or AutoCAD.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
Nice To Haves
- Three 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 such as MATLAB, Python, or C++.
- Experience in a manufacturing environment.
- Certification from a professional engineering body, such as PE or CQE.
Responsibilities
- Design and develop medical devices, including sterilization packaging, biological and chemical indicators, and other technical products, in compliance with regulatory standards such as FDA, ISO, and CE.
- Assist with research into new and emerging sterilization modalities and test systems.
- Develop and execute test protocols, including validation and verification processes.
- Collaborate 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, performance, and manufacturability.
- Document designs, protocols, test results, and regulatory submissions.
- Assist with risk management, including hazard analysis and failure mode analysis.
- Participate in quality assurance and compliance initiatives to meet safety and effectiveness standards.
- Perform other responsibilities designated by the manager.
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What This Job Offers
Job Type
Full-time
