ConsumablesDesignEngineer

## Accountabilities The role is responsible for leading the design, development, testing, and validation of consumable components and assemblies used in diagnostic platforms. You will translate product and system requirements into manufacturable designs while ensuring compliance with regulatory and quality standards. Key responsibilities include: Designing plastic-based consumables and assemblies using CAD tools, engineering drawings, and simulation methods Developing prototypes and executing verification and validation testing throughout the product lifecycle Applying design-for-manufacturing principles to optimize cost, scalability, and assembly efficiency Collaborating with cross-functional teams including R&D, quality, operations, and suppliers to support product development and transfer Maintaining technical documentation including design history files, risk assessments, and test reports Supporting tooling, fixtures, and test method development for lab and production environments Ensuring compliance with medical device quality systems and regulatory requirements Requirements The ideal candidate brings a strong engineering background combined with hands-on product development experience in consumables or plastic components. The role requires both technical depth and the ability to work in a fast-paced, collaborative environment. Key qualifications include: Bachelor’s degree in Mechanical Engineering, Materials Science, Plastics Engineering, or related field (Master’s preferred or equivalent experience) 1+ years of experience in product design and development, or equivalent advanced degree experience Strong proficiency in CAD software (e.g., SolidWorks or equivalent) Experience with plastic part design, prototyping (3D printing, CNC), and engineering drawings Familiarity with design-for-manufacturing (DFM) principles and supplier collaboration Ability to execute and interpret verification testing and support validation activities Strong problem-solving skills, at