Collaborate with Manufacturing, Quality, Engineering, Regulatory, and R&D teams to support ... Biomedical Sciences). * Entry-level candidates are acceptable. Required Skills & Qualifications
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Collaborate with Manufacturing, Quality, Engineering, Regulatory, and R&D teams to support ... Biomedical Sciences). * Entry-level candidates are acceptable. Required Skills & Qualifications
Entry Level Biomedical Engineer information
What Does an Entry Level Biomedical Engineer Do?
Entry-level biomedical engineers perform a wide variety of tasks, such as research, writing technical reports, and making informed recommendations based on research to clinicians, hospital management, engineers, and the public. They also evaluate, design, and use biomedical equipment like artificial organs, artificial body parts, and diagnostic devices. As a junior biomedical engineer, you may begin your career under the guidance of an experienced engineer or professional, gaining additional duties and responsibilities as you progress in your training and knowledge of the health care field.
What are the key skills and qualifications needed to thrive as an Entry Level Biomedical Engineer, and why are they important?
To thrive as an Entry Level Biomedical Engineer, you need a bachelor's degree in biomedical engineering or a related field, strong analytical skills, and a solid understanding of biology and engineering principles. Familiarity with CAD software, laboratory instrumentation, and regulatory standards such as FDA guidelines is typically required. Strong problem-solving abilities, teamwork, and effective communication are valuable soft skills in this role. These skills are crucial for developing safe, effective medical devices and collaborating across multidisciplinary teams to meet patient and industry needs.
What types of projects do entry level biomedical engineers typically work on, and how do they contribute to larger teams?
As an entry level biomedical engineer, you’ll often assist with tasks such as testing medical devices, supporting research and development, and performing data analysis for ongoing projects. You’ll work closely with senior engineers, scientists, and sometimes clinicians to collect and interpret data, ensure regulatory compliance, and help troubleshoot technical issues. Collaboration is a key part of the role, as your contributions support the successful development and improvement of healthcare technologies. Over time, you’ll gain exposure to more complex responsibilities and opportunities for advancement as you build your technical and teamwork skills.
What is the difference between Entry Level Biomedical Engineer vs Biomedical Technician?
| Aspect | Entry Level Biomedical Engineer | Biomedical Technician |
|---|---|---|
| Required Credentials | Bachelor's degree in biomedical engineering or related field | Associate's or bachelor's degree in biomedical technology or related field |
| Work Environment | Design, develop, and test medical devices; work in labs or offices | Maintain, repair, and calibrate medical equipment; work in hospitals or clinics |
| Employer & Industry Usage | Medical device companies, healthcare facilities, research institutions | Hospitals, clinics, medical equipment suppliers |
Entry Level Biomedical Engineers focus on designing and developing medical devices, requiring a bachelor's degree in biomedical engineering. Biomedical Technicians primarily maintain and repair medical equipment, often with an associate's or bachelor's degree in biomedical technology. Both roles are essential in healthcare, but they differ in responsibilities, work environment, and required credentials.
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Full-time
Posted 12 days ago
Job description
Main Responsibilities:
- Support EO sterilization and microbiological testing activities within a regulated manufacturing environment.
- Perform microbiological analyses on raw materials, in-process materials, release samples, and stability samples.
- Prepare, clean, disinfect, sterilize, store, and handle laboratory instruments, materials, products, and supplies.
- Support sterilization validations including protocol execution, documentation, and report preparation.
- Interpret and evaluate analytical results against established specifications and support corrective action activities when necessary.
- Assist in developing, validating, and implementing controlled environment methods and laboratory procedures.
- Perform qualitative and quantitative testing using standard laboratory equipment and automated instrumentation.
- Support methodology transfer activities from R&D into manufacturing or laboratory operations.
- Maintain accurate technical documentation, validation records, protocols, and reports in compliance with GDP requirements.
- Collaborate with Manufacturing, Quality, Engineering, Regulatory, and R&D teams to support sterilization and microbiological initiatives.
- Participate in continuous improvement activities related to sterilization, laboratory operations, and microbiological processes.
- Follow FDA regulations, ISO standards, and company quality procedures.
- Minimum 3 year of relevant experience in the regulated industry.
- Bachelor’s degree in Science (Microbiology, Biology, Biotechnology, Biomedical Sciences).
- Entry-level candidates are acceptable.
- Knowledge of EO sterilization processes.
- Familiarity with FDA regulations, ISO 11135, ISO 11737, and related sterilization and microbiological standards.
- Strong technical documentation and report-writing skills.
- Ability to support sterilization validations, protocols, and testing activities.
- Strong analytical and problem-solving skills.
- Ability to communicate findings clearly and collaborate effectively with cross-functional teams including Manufacturing, Quality, Regulatory, and R&D.
- Fully bilingual (English and Spanish).
- Experience in regulated manufacturing, pharmaceutical, biotechnology, or medical device industries.
- Experience with TrackWise or similar quality management systems.
- Knowledge of environmental monitoring and controlled environments.
- Exposure to validation and laboratory quality systems.
- Microsoft Office Suite
- TrackWise
- Agile environment exposure
- Technical documentation
- Sterilization validation support
- Microbiological testing techniques
- Controlled environment practices
- 100% on site job
- Full time job
- 1 year of first contract term with expectation of continuity based on performance and budget
- Location: Salinas, PR
- Administrative shift
- Type of industry: Medical devices
About CIS International
Sourced by ZipRecruiter
Company size
11 - 50 Employees
Headquarters location
Gardena, CA, US
Year founded
1991