Senior Mechanical Engineer - Consumables Design

Position Summary for Senior Mechanical Engineer

The Senior Mechanical Engineer leads mechanical design of disposable and consumable components for life-science instruments and medical devices. This role brings deep, hands-on expertise in plastics design, injection molding, and plastics joining/welding for IVD and human-use medical device consumables, along with a strong command of design for user experience, human factors, and bioburden/sterility control. The skill set is intended to support an ongoing portfolio of related development programs (for example, dialysis and other extracorporeal consumables, diagnostic cartridges or cassettes, drug-delivery consumables, and other single-use fluidic or reagent-handling components). The Senior Mechanical Engineer partners closely with chemical, systems, electrical, software, and human factors engineering to integrate fluidic, chemistry, controls, and usability requirements into manufacturable, reliable, and user-friendly consumable designs, while providing technical leadership and credible client interface throughout each program.

Key Responsibilities

Consumable & Plastics Design

• Lead mechanical design of consumable/disposable components (e.g., cartridges, cassettes, fluid-path sets, connectors, filters) for life-science instruments and medical devices. • Apply best-practice plastics design principles (wall thickness, draft angles, ribs/bosses, gate and parting-line placement) to ensure part manufacturability and performance. • Specify and validate plastics joining and welding methods (ultrasonic welding, heat staking, solvent bonding, laser welding) appropriate for fluid-path integrity and biocompatibility. • Evaluate materials for chemical compatibility and biocompatibility, partnering with Quality and Regulatory as needed. • Design sterile barrier packaging systems (e.g., pouches, trays, seals) suited to the target sterilization modality and shelf-life requirements. • Apply design-for-user-experience and human factors principles (IEC 62366) to consumable design, including error-proofing, tactile/visual feedback, and ease of loading for both clinical and home-use operators. • Design consumables for bioburden control and sterility assurance, including material selection and compatibility with sterilization modalities (EtO, gamma, e-beam). • Lead design-for-manufacture (DFM) and design-for-assembly (DFA) reviews with internal manufacturing/operations teams as well as external tooling vendors and contract manufacturing partners, including tolerance stack-up and GD&T analysis. • Lead verification testing of consumables (e.g., burst/leak testing, drop/shock, fatigue, shelf-life) to support design verification and validation. Lead process validation efforts for consumables. • Support pilot builds and design-transfer activities, ensuring consumable designs are robust for high-volume manufacturing.