Engineer III, Product Design

Quick Facts

The Engineer III, Product Design role in the Vascular Access Product Engineering team drives the design, development, and implementation of medical devices, ensuring regulatory standards and customer expectations are met.

Description

This position acts as a subject matter expert (SME) in medical device development, leading key projects of significant complexity using sound engineering principles, experimental methods, and analytical techniques. The role emphasizes strong experience in documentation, testing, and risk management, while collaborating with cross-functional teams including marketing, commercial, quality, regulatory, and medical groups.

Responsibilities

• Drive Design Control Activities: Requirements Management, Design Outputs, Verification & Validation (V&V), Design History File (DHF), and Risk File management.
• Drive Product Development: Plan, design, and implement new products and post-market changes in compliance with applicable medical device standards.
• Solve Complex Engineering Challenges: Apply experimental, computational, and analytical methods to ensure product performance.
• Develop and Maintain Technical Documentation: Specifications, requirements, architecture, design, and usability documents.
• Conduct and Oversee Testing: Exploratory, bench, and V&V testing; create test protocols; generate comprehensive reports.
• Collaborate with Cross-Functional Teams: Align design requirements with business objectives and regulatory compliance.
• Support Corrective and Preventable Actions: Root cause analysis and solutions for non-conforming events.
• Design & Model Devices: Use SolidWorks to create and refine device models for high-volume disposable medical devices.
• Partner with Suppliers & Customers: Ensure manufacturability with emphasis on plastics/polymer engineering and injection molding.

Requirements

• Extensive hands-on medical device design and development experience; knowledge of FDA regulations and ISO standards.
• Strong SolidWorks proficiency for 3D modeling and drafting, including design for manufacturability.
• Deep understanding of medical-grade plastics, injection molding principles, and common joining methods.
• Ability to apply statistical methods, including Design of Experiments (DOE) and tolerance analysis.
• Effective communication with technical and non-technical stakeholders and suppliers.
• Solid understanding of mechanical design principles (engineering mechanics & physics) and basic machine shop practices.
• Ability to manage multiple priorities and meet deadlines under pressure.

Minimum Qualifications

• BS in Mechanical Engineering or related field from an accredited institution.
• At least 4 years of relevant experience in medical device design and development.
• At least 18 years of age.

Benefits

Not specified in provided text.