Biomed 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 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.
