R&D Product Engineer II

The R&D Product Engineer II will report into the Wound Management (WM) RPE Team within the WM Center of Excellence (COE) group of R&D. They will focus on supporting changes to existing products to meet customer needs and maintain our wound management product lines. They will serve as the design owner and technical expert, supporting released product engineering teams by planning, developing, and executing design changes, testing and analysis activities during product change implementation. This role focuses on driving improvements in product performance and manufacturability, reducing cost, improving quality and ensuring supply continuity while maintaining design intent. Specifically, the R&D Product Engineer II will focus on mechanical design and packaging design relating to absorbable medical devices, inside the sterile barrier.

A Day in the Life

• Designs, develops, analyzes, troubleshoots, and provides technical support during product development and manufacturing.
• Works independently under general supervision to determine and develop approach to solutions.
• Designs studies to investigate root cause or identify process parameters.
• Updates engineering drawings and specifications with CAD software; conducts tolerance stacks and evaluations of design changes.
• Proposes design improvements to components or products to improve quality, cost, or manufacturability.
• Provides design input for changes and new tooling of injection molded components.
• Involved in activities to support product development, improvements to existing products and pre-clinical studies.
• Defines and performs verification and validation activities ensuring products meet user needs and intended use.
• Guides the conceptualization of new methodologies, materials, machines, or processes related to existing product manufacturing and design.
• Coordinates activities with outside suppliers and consultants to ensure timely delivery.
• Writes engineering reports and creates presentations as required to document and communicate results.
• Collaborate with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.
• Supports technical evaluations for OEM, BD&L, and commercial driven evaluations with a focus on design ownership.
• Conducts design analysis of customer complaints and returned products, partnering with Design Quality and Manufacturing to identify root cause and implement corrective actions.
• Partners cross-functionally with Design Quality Engineering, Manufacturing Engineering, Plant Quality Engineering, Operations, and Supply Chain.

Minimum Requirements

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Manufacturing, or related engineering discipline required).
• Bachelors degree in Engineering, plus 2 years relevant work experience, OR a Master’s degree in Engineering, with 0-2 years work experience.

Preferred Qualifications

• Experience supporting medical devices, particularly wound management and absorbable medical products.
• Hands-on experience with product packaging design, inside of sterile barrier.
• Experience with medical device product and component mechanical design through CAD programs, tolerance stacks, and analytical modeling.
• Experience with injection molded components and tooling.
• Hands-on experience with root cause analysis, design verification, design validation, and supplier collaboration.
• Familiarity with ISO 13485, FDA Quality System Regulations, and design control/change management processes.
• Experience analyzing customer complaints, product returns, or field issues.
• Strong communication skills with the ability to work effectively across technical and non-technical teams.