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.

Technical Leadership & Client Interface

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.

Cross-Functional Collaboration

Partner with process- and materials-focused engineering colleagues to ensure fluid-path materials and geometries meet chemical compatibility, biocompatibility, and performance requirements.

Partner with Systems Engineering to ensure consumable-level requirements are captured, traced, and verified within the system design-control framework.

Coordinate with Quality and Regulatory on biocompatibility (ISO 10993), sterilization validation, and design-history-file documentation.

Collaborate with Operations and Supply Chain on tooling strategy, supplier qualification, and scale-up planning.

Qualifications
Required

BS in Mechanical Engineering; MS preferred.

7+ years of mechanical design experience, with significant focus on disposable/consumable components for IVD or human-use medical devices.

Deep, hands-on expertise in plastics design and injection molding, including resin selection, tooling considerations and DFM/DFA practices for both internal and external manufacturing.

Experience with die cutting, coating, converting and associated processes utilized in the production of high-volume consumables.

Direct experience specifying and validating plastics joining/welding methods (ultrasonic welding, heat staking, solvent bonding, or laser welding).

Demonstrated experience applying human factors and user-experience principles to consumable or disposable product design.

Working knowledge of labeling and primary and secondary packaging.

Working knowledge of sterilization modalities, bioburden control, and sterile packaging design for medical device consumables.

Proficiency with GD&T, tolerance stack-up analysis, and CAD tools (e.g., SolidWorks).

Strong leadership and written/verbal communication skills, with demonstrated ability to lead technically and interface credibly with clients.

Preferred

Experience with fluid-path or wetted consumable design (e.g., cartridges, tubing sets, filters) in dialysis, infusion/IV therapy, diagnostics, or similar applications.

Familiarity with ISO 10993 biocompatibility testing and sterilization validation (ISO 11135, ISO 11137).

Experience designing consumables for home-use or lay-user environments.

Proficiency with AI tools.

Patent experience in consumable or disposable medical device design.

This role is onsite in San Diego. Salary range: $150,000-$185,000 plus benefits, PTO and 401k with matching

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