Job Summary We are seeking a dynamic and innovative R&D Engineer - Engineering Professional to join our cutting-edge research and development team. In this role, you will drive the design, development, and validation of advanced biomedical devices and technologies. Your expertise will contribute to creating innovative solutions that meet regulatory standards and improve patient outcomes. This position offers an exciting opportunity to work at the forefront of biomedical engineering, leveraging your technical proficiency and project management skills to bring impactful products from concept through production. Responsibilities Lead engineering product development projects, ensuring alignment with design controls, regulatory requirements (such as FDA regulations and

ISO 13485

), and quality standards like GMP and GLP. Design and develop mechanical components and systems using CAD software such as SolidWorks and other 3D modeling tools, focusing on medical device specifications. Conduct experiments, design of experiments (DOE), and statistical analysis to optimize device performance, biocompatibility, and manufacturing processes. Collaborate cross-functionally with biochemists, molecular biologists, clinical teams, and manufacturing engineers to integrate multidisciplinary insights into product designs. Perform laboratory testing, cell culture experiments, assays, and mechanical testing to validate device functionality and compliance with biomedical regulatory standards. Analyze data from research activities using Python or other data analysis tools to inform iterative design improvements. Ensure all engineering activities adhere to regulatory/legal compliance standards such as FDA regulations, ISO 13485, GMP, CGMP, and GLP for medical device development. Experience Proven experience in biomedical engineering or related fields with a strong background in mechanical design, research, or product development within the medical device industry. Hands-on laboratory experience including cell culture techniques, assays, molecular biology methods, and biomedical regulatory compliance. Demonstrated proficiency in CAD software (SolidWorks or equivalent), 3D modeling for product design, GD&T (Geometric Dimensioning & Tolerancing), and engineering validation processes. Familiarity with project scheduling, project management methodologies, and cross-functional collaboration in a fast-paced R&D environment. Strong understanding of statistical analysis for research purposes and experimental design principles in a regulated setting. Knowledge of manufacturing processes related to medical devices including testing protocols for clinical trials and device validation under GMP/GLP conditions. Excellent data analysis skills using Python or similar tools combined with a solid foundation in math and engineering principles. Join us to innovate at the intersection of science and engineering! This role is perfect for passionate professionals eager to develop life-changing biomedical solutions while advancing their expertise in a collaborative environment committed to excellence in medical device innovation.

Benefits:

401(k) 401(k) matching Dental insurance Disability insurance Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person