Senior Mechanical Engineer - Consumables Design

Job Category : Engineering

Requisition Number : SENIO
001769

• Posted :
  September 29, 2026
• Full-Time
• On-site

Showing 1 location

Ascential Medical & Life Sciences
San Diego, CA 92127, USA

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.

• 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.

• Serve as the technical authority on consumables design, manufacturability, and human factors across the program portfolio.
• Present mechanical design status, risk assessments, and manufacturability trade‑offs at design reviews and client meetings.
• Mentor mechanical engineers on plastics design, DFM/DFA for both internal and external manufacturing, and sterility/bioburden best practices.
• Represent the mechanical/consumables workstream credibly to clients, balancing innovation, manufacturability, and program constraints.

• Partner with process­-and materials‑focused engineering…