Biomedical Engineer

Biomedical Engineer Biomed company Santa Clara, CA Job Details Full-time $40.00 - $98,669.56 an hour 12 hours ago Qualifications Mechanical product design layouts Biology research Teamwork Product development project management Project engineering Project documentation ISO standards GD&T Master's degree Clinical research compliance Laboratory compliance Project management in healthcare Design engineering Blueprint creation using CAD software Schedule creation Design controls Biomedical regulatory compliance Managing projects GMP for research safety and compliance Research findings presentation Healthcare compliance Mechanical knowledge Cross-functional communication FDA regulations Data analysis software Mechanical product development projects Scientific reports Molecular analysis Full Job Description Job Summary We are seeking a dynamic and innovative Biomedical Engineer to join our cutting-edge research and development team. In this role, you will leverage your expertise in biotechnology, mechanical engineering, and molecular biology to design, develop, and optimize medical devices and diagnostic tools. Your work will contribute to advancing healthcare solutions that improve patient outcomes worldwide. This position offers an exciting opportunity to collaborate across multidisciplinary teams, manage complex projects, and bring innovative biomedical products from concept to manufacturing readiness. Responsibilities Lead the design and development of biomedical devices, ensuring compliance with FDA regulations, ISO standards, and design controls. Utilize CAD software such as SolidWorks and other CAD tools to create detailed mechanical designs and prototypes. Conduct laboratory experiments including assays, cell culture, and molecular biology techniques to validate device performance. Perform statistical analysis on experimental data to inform design improvements and ensure product reliability. Manage project schedules effectively, coordinating research activities, testing phases, and manufacturing timelines. Collaborate with cross-functional teams on project management tasks, including risk assessment and documentation for regulatory submissions. Support clinical trials by preparing protocols, analyzing results, and ensuring adherence to GLP (Good Laboratory Practice) and CGMP (Current Good Manufacturing Practice) standards. Requirements Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Biotechnology, or a related field. Proven experience with laboratory techniques such as assays, cell culture, and biochemistry methods. Strong knowledge of CAD software (SolidWorks or equivalent), GD&T (Geometric Dimensioning & Tolerancing), and mechanical design principles. Familiarity with molecular biology techniques and statistical analysis tools for research validation. Experience managing projects using project scheduling tools and methodologies in a biomedical context. Understanding of FDA regulations, ISO standards applicable to medical devices, design controls, GLP, CGMP practices, and clinical trial processes. Proficiency in programming languages such as Python for data analysis or automation tasks is a plus. Excellent communication skills with the ability to document research findings clearly and collaborate effectively across teams. Join us in shaping the future of healthcare technology! We are committed to fostering an inclusive environment where innovation thrives through dedicated teamwork. This paid position offers valuable hands-on experience in biomedical device development while contributing meaningfully to life-changing medical advancements.

Pay:

$40.00 - $98,669.56 per hour

Work Location:

In person