OEM R&D Sr. Staff Engineer

B. Braun seeks an OEM R&D Sr. Staff Engineer to lead development of innovative infusion, nutrition, and pain management products. You will own full product lifecycle from concept through design, verification, and technical transfer, ensuring compliance with FDA, ISO 13485, and cGMP. Partner with OEM customers and cross-functional teams to define requirements, execute DOEs, manage risk, and deliver robust, manufacturable designs.

Mentor engineers, drive continuous improvement, and support a culture of safety, learning, and collaboration that advances patient care worldwide.

Responsibilities

• Lead end-to-end R&D for OEM infusion, nutrition, and pain management products.
• Translate customer and clinical requirements into robust design specifications.
• Plan and execute design verification, validation, and DOEs.
• Ensure compliance with FDA regulations, ISO 13485, and c
• GMP standards.
• Drive risk management activities including FMEA and design reviews.
• Collaborate with manufacturing to enable efficient technical transfer and scale-up.
• Manage OEM technical relationships and provide expert engineering guidance.
• Generate and maintain engineering documentation, reports, and design history files.
• Mentor junior engineers and support a culture of continuous learning and safety.
• Identify and implement R&D process improvements to enhance quality and efficiency.

Required Skills

• Medical device design and development
• Biotechnology/pharmaceutical product development
• Design of experiments (DOE)
• CAD and engineering documentation
• Risk management (FMEA, ISO 14971)
• Design verification and validation
• Regulated environment (FDA, ISO 13485, c
• GMP)
• Project management
• Technical transfer to manufacturing
• Data analysis and technical reporting