Biomedical Engineer

Job Overview

We are seeking a dynamic and innovative Biomedical Engineer to join our team and drive the development of cutting-edge medical devices and healthcare solutions. In this role, you will leverage your expertise in biomedical engineering, mechanical design, and regulatory standards to create safe, effective, and compliant products that improve patient outcomes. Your passion for research, technical proficiency, and collaborative spirit will be essential as you contribute to all phases of product development from concept to manufacturing. This paid position offers an exciting opportunity to make a meaningful impact in the healthcare industry while working within a fast-paced, innovative environment.

Responsibilities

• Lead the design and development of medical devices by applying principles of biomedical engineering, mechanical engineering, and CAD software such as SolidWorks and other CAD tools.
• Conduct experiments, assays, cell culture studies, and molecular biology research to validate device functionality and biocompatibility.
• Develop detailed 3D models for product design, ensuring mechanical integrity and compliance with GD&T standards.
• Collaborate cross-functionally with research teams, regulatory specialists, manufacturing engineers, and clinical staff to ensure seamless project execution.
• Design experiments and analyze data using statistical methods to optimize device performance and validate engineering validation processes.
• Ensure all product development adheres to regulatory standards including FDA regulations, ISO, GMP, GLP, CGMP, and design controls.
• Support manufacturing processes by participating in design of experiments (DOE), process validation, testing protocols, and quality assurance activities aligned with regulatory compliance.

Requirements

• Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Biotechnology or related field; PhD preferred.
• Proven experience with medical device design, testing, and regulatory compliance standards such as FDA regulations and ISO.
• Strong proficiency in CAD software (SolidWorks or equivalent), 3D modeling for product design, GD&T principles, and engineering validation techniques.
• Hands-on laboratory experience with assays, cell culture techniques, laboratory testing methods, and experimental design.
• Knowledge of biomedical regulatory frameworks including GMP, GLP, CGMP for manufacturing and clinical trials.
• Excellent data analysis skills using statistical analysis tools; experience with Python or similar programming languages is a plus.
• Ability to manage multiple projects through project scheduling and project management methodologies while maintaining attention to detail.
• Effective communication skills for cross-functional collaboration across research teams, manufacturing units, and regulatory bodies.

Join us in advancing healthcare technology by designing innovative solutions that meet rigorous safety standards! This role offers an engaging environment where your expertise will directly influence the future of medical devices—empowering better patient care worldwide.

Pay: $16.00 - $20.00 per hour

Work Location: In person

Salary : $16 - $20