Work Flexibility: Hybrid or Onsite
We are seeking a Senior Mechanical Engineer to support the development and lifecycle management of disposable fluid-path components within our Urology portfolio. This role will focus on injection-molded plastic components and assemblies, including cartridges, cassettes, tubing systems, connectors, sealing interfaces, locking mechanisms, and other flow-control components integrated into electromechanical medical devices.
The engineer will divide their time between sustaining existing products and supporting the development of new tubing and disposable solutions. The role places particular emphasis on supplier collaboration, product lifecycle ownership, injection-molded plastic design, and the resolution of design, manufacturing, and field-related issues.
You will serve as a primary technical interface with suppliers while partnering with an experienced plastics subject matter expert and cross-functional teams in Quality, Manufacturing, Advanced Operations, Supplier Quality, and Sourcing. This team structure provides strong technical mentorship and support while allowing the engineer to build ownership of assigned components and projects.
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.
- $101,000 - $168,400 USD Annual
Travel Percentage: 10%
