Challenging career opportunity be an integral part of a high performing team that develops, maintains, and enhances software controlled electromechanical medical devices, using advanced technologies. This established and growing company has a successful product line of sophisticated, lifesaving medical devices distributed around the world. The creative Systems Engineer in this role will apply his or her engineering expertise to improve, create, and analyze designs, and contribute to development of capital equipment from invention and prototype through pilot manufacturing and process validation.
- Think creatively and practically to drive development of new devices, as well as improvements to current products.
- Design, develop, analyze and document designs per FDA, ISO, and Company regulations and design control guidelines.
- Research and analyze information from customer requirements, standards, and commercial trends to determine feasibility of designs or applications.
- Coordinate and lead a cross-functional team, employing project management techniques.
- Provide expertise for the identification and correction of product and manufacturing issues.
- Perform, evaluate and report testing and Verification and Validation in accordance with ISO, FDA and company design control guidelines.
- Apply knowledge of design for reliability, testability and manufacturability.
- Predict time needed to complete projects, and help assure schedule adherence or adjustment.
- BS in engineering, mathematics, computer science, or related disciplines.
- 2+ Years medical product and systems design, validation, testing, and DFM experience.
- Knowledge of FDA, GMP, ISO, IEC and design control standards, testing, and processes.
- Experience with requirements and data analysis in a product development environment.
- Knowledgeable of state of the art manufacturing processes using plastics, and /or 3-D printing.
- Advanced skills with Excel; Visual Basic scripting ability is a plus.
- Experience using quantitative software, MATLAB, Minitab or the like is a plus.
- Excellent oral and written communication skills.
US Citizenship or Permanent Resident status is required