Sr. Mechanical Engineer -Disposables

What You Will Do

• Translate customer and product needs into engineering requirements, specifications, and mechanical designs for disposable fluid-path components.
• Support the design and development of cartridges, cassettes, tubing systems, connectors, sealing interfaces, locking mechanisms, and other plastic components.
• Create and evaluate design concepts through prototyping, engineering analysis, and proof-of-concept testing.
• Develop 3D models, engineering drawings, tolerance analyses, and GD&T documentation.
• Apply injection-molding design principles, including material selection, part geometry, dimensional requirements, tooling considerations, and manufacturing feasibility.
• Lead technical collaboration with suppliers during concept development, design reviews, tooling development, component qualification, and production support.
• Evaluate supplier capabilities and work with Supplier Quality and Sourcing to address quality, cost, delivery, and manufacturability requirements.
• Review supplier-proposed concepts and provide technical recommendations based on product performance, design requirements, and manufacturing risk.
• Plan, execute, analyze, and document design verification testing.
• Support design transfer, engineering builds, process validation, and the introduction of new or modified components into production.
• Investigate product, manufacturing, and field issues using structured root-cause analysis and corrective-action methods.
• Identify opportunities to improve product reliability, manufacturability, quality, and cost.
• Maintain design documentation and contribute to design controls, risk-management activities, and the Design History File.
• Communicate technical decisions, risks, recommendations, and project status to internal stakeholders and external suppliers.

Minimum Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline is required.
• Two or more years of product-development experience is required.
• Experience designing injection-molded plastic parts or small plastic components is required.

Preferred Qualifications

• Understanding of plastic-material selection, manufacturing processes, and injection-molding design principles.
• Experience creating 3D models and engineering drawings using GD&T.
• Experience with tolerance analysis, design verification testing, and root-cause investigation.
• Knowledge of mechanical engineering principles, including mechanics of materials, component design, and manufacturing processes.
• Ability to communicate technical information clearly and collaborate with internal teams and external suppliers.
• Experience with disposable medical products, fluid-path components, tubing systems, connectors, seals, or flow-control mechanisms.
• Experience working directly with suppliers on component design, tooling, manufacturability, qualification, or quality improvement.
• Experience supporting both new product development and sustaining or lifecycle engineering.
• Familiarity with supplier quality processes, PPAP, process validation, or production-part qualification.
• Experience applying statistics, design of experiments, or systematic problem-solving methods.
• Experience developing products within a regulated industry.
• Familiarity with medical-device design controls, risk management, FDA requirements, or ISO 13485.
• Experience supporting field investigations, customer complaints, nonconformances, or corrective and preventive actions.

Benefits

• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.