Mechanical Design Engineer About the role The Mechanical Design Engineer will be part of a small and nimble product development group that is creating revolutionary devices to improve sample collection and integrity for critical in-vitro diagnostic (IVD) tests. The right candidate(s) will have the practical background and intuition to devise multiple solutions to challenging mechanical problems, the hands-on expertise to build and test them, the engineering fundamentals to understand why they behave the way they do, and the ability to turn all this into an elegant easy-to-use product. The right individual to join our team is a self-starter with a dive in and get-it-done approach to trying new ideas, prototyping, and solving problems. He or she will be motivated to create products that work elegantly to solve real clinical problems, help patients, and make the job better and easier for clinicians. This is a full time position in our downtown Seattle office. The following are required: • Expertise in high-volume injection-molded plastics design • Experience with mechanisms and seals • Prototyping know-how, with the ability to be hands-on in the lab • Proficiency in Solidworks, or other parametric CAD software platforms • Working knowledge of fluidics and/or microfluidics • Competence in statistical methods to establish product specifications, develop tests, and analyze data • Effective implementation of Root Cause Analysis (RCA) tools to identify the source of device/product issues • Experience with LabVIEW graphical programming environment (preferred) • Experience with other programming languages such as Python or C/C++ in Arduino environment (preferred) Core responsibilities will include the following: • Lead and collaborate with colleagues to engineer new medical devices, including concept generation and prototyping • Design and test new products, bring them to manufacturing, and support their release to the market • Work with healthcare professionals on user needs and user-centric product design About you • Experience developing mechanical or electromechanical products in a team environment • 8+ years for senior-level candidates • 3-6+ years for intermediate-level candidates • Bachelor degree in Mechanical Engineering or related field with applicable skills • Strong knowledge of prototyping methods and success working with rapid-prototyping resources • Ability to work independently and lead project efforts • Medical device design background, with a practical grasp of FDA Quality System Regulations (preferred) • Experience with external contract manufacturing, test laboratories, and certification partners (preferred) • Ability to work onsite in our downtown Seattle office 5 days / week, some minimal travel may be required occasionally • Ability to work in an office and laboratory setting, using computers, fine motor skills and excellent hand dexterity with the ability to lift up to 25lbs occasionally