Biomedical Engineer

Biomedical EngineerPositioned 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 educationMaster'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 CompetenciesStrong analytical and problem-solving skills.Excellent communication and teamwork abilities.Equal Employment Opportunity & Accessibility StatementHuFriedyGroup 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 View phone number on click.appcast.io. We are committed to supporting you throughout your journey with HuFriedyGroup!