• Develops new concepts from initial design to market release.
• Investigates and evaluates existing technology.
• Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.
• Conducts feasibility studies of the design to determine ability to function as intended.
• Maintains detailed documentation throughout all phases of research and development.
• Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs.
• Conduct risk analysis for products under development.
• Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
• Any other duties as assigned.
• Bachelor Degree in mechanical engineering or biomedical engineering.
• 5 years of relevant experience in product design and development
• Practical and demonstrated experience of solid modeling of parts and assemblies.
• Experience in the design and development of products in accordance with ISO 13485 guidelines.
• Demonstrated hands-on experience with Design Control procedures.
• Proficient in 3D CAD software (SolidWorks preferred).
• Strong aptitude for hands-on engineering testing and experimentation in a lab/shop environment.
• Able to identify, break down and solve a variety of difficult technical problems.
• Team player with excellent interpersonal and communication skills.
• Proven ability to work independently.
• Disciplined and well-organized in documentation
• Knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.).