Associate Product Development Engineer - Medical Devices

As an Associate Product Development Engineer, you support implementation and lifecycle management of infusion and related medical products. Working on-site with R&D, Quality, Regulatory, Manufacturing, and global teams, you plan and execute testing and validation, analyze data, document findings, and help ensure FDA/ISO compliance while contributing to product improvements and patient safety initiatives.

Responsibilities

• Support new product implementation and lifecycle management for medical devices and pharmaceutical products
• Lead and coordinate multiple engineering projects with cross-functional and global teams
• Plan and execute product testing, validation, and technical investigations
• Analyze engineering data to diagnose issues and recommend design or process improvements
• Prepare, organize, and maintain technical documentation, reports, and engineering records
• Ensure engineering activities comply with FDA and ISO quality system requirements
• Contribute to continuous improvement initiatives to enhance product quality and manufacturing efficiency
• Collaborate with Quality, Regulatory, Procurement, and Manufacturing to resolve product issues

Required Skills

• Product development and lifecycle engineering
• Medical device testing and validation
• Data analysis and statistical interpretation
• Design control and technical documentation
• FDA 21 CFR Part 820 compliance
• ISO 13485 quality management systems
• Risk management per ISO 14971
• Project coordination in cross-functional teams
• Continuous improvement and root cause analysis
• Laboratory and basic manufacturing process familiarity