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Biomedical Engineer
Overview
Join our innovative team as a Biomedical Engineer and play a pivotal role in advancing healthcare technology through cutting-edge research, design, and development. In this dynamic position, you will leverage your expertise in biotechnology, mechanical engineering, and molecular biology to create and optimize medical devices, laboratory equipment, and clinical solutions. Your work will directly impact patient outcomes by ensuring products meet rigorous safety standards and regulatory requirements. This role offers an exciting opportunity to collaborate across multidisciplinary teams, manage complex projects, and contribute to groundbreaking medical innovations that improve lives worldwide.
Duties
- Design, develop, and test biomedical devices and systems using CAD software such as SolidWorks and other mechanical design tools.
- Conduct research on biochemistry, cell culture, assays, and molecular biology techniques to inform product development.
- Manage project schedules, coordinate timelines, and oversee project management tasks to ensure timely delivery of engineering solutions.
- Perform statistical analysis on experimental data to validate device performance and compliance with FDA regulations, ISO standards, CGMP (Current Good Manufacturing Practice), and GLP (Good Laboratory Practice).
- Develop and implement design controls throughout the product lifecycle, from initial concept through manufacturing and clinical trials.
- Collaborate with manufacturing teams to optimize production processes while adhering to FDA regulations and ISO standards specific to the locale.
- Conduct laboratory experiments involving assays, cell culture, mechanical testing, and other laboratory techniques to support research initiatives.
- Prepare detailed documentation for regulatory submissions, including design verification/validation reports and technical files.
- Utilize programming languages such as Python for data analysis or automation tasks related to biomedical research or device testing.
- Support clinical trials by designing experiments, analyzing results, and ensuring compliance with all relevant regulatory guidelines.
Skills
- Strong knowledge of biotechnology principles combined with expertise in mechanical engineering design.
- Proficiency in CAD software such as SolidWorks and familiarity with GD&T (Geometric Dimensioning & Tolerancing).
- Experience with project scheduling tools and project management methodologies to coordinate complex initiatives effectively.
- Solid understanding of FDA regulations, ISO standards (specific to the location), CGMP, GLP, and design controls applicable to medical device development.
- Laboratory experience working with assays, cell culture techniques, molecular biology methods, and biochemistry protocols.
- Skilled in statistical analysis for experimental data interpretation using appropriate software tools.
- Familiarity with manufacturing processes related to biomedical devices or laboratory equipment.
- Knowledge of clinical trial procedures and regulatory documentation requirements for medical devices or pharmaceuticals.
- Ability to work collaboratively across multidisciplinary teams while managing multiple projects simultaneously. Embark on a rewarding career where your skills drive innovation in healthcare technology! We are committed to fostering a vibrant environment that supports your growth while making a meaningful difference in patients’ lives worldwide.
Pay: $73,763.16 - $88,833.05 per year
Work Location: In person
