Senior Software Quality & Design Assurance Engineer (Hybrid)

B. Braun Melsungen AG; Bethlehem (Northampton County); Hybrid; USD 92,000 - 115,000; Full time

Job summary

B. Braun Medical Inc. is seeking a Sr Design Assurance Engineer (Software Medical Devices) in Bethlehem, PA.

The role leads quality and compliance activities for embedded and standalone software across product development and commercialization, ensuring adherence to regulatory and customer requirements. The position requires a Bachelor's degree in Engineering and 6+ years of relevant experience, with expertise in Design Controls, V&V, Risk Management, and medical device software regulations.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 6+ years related experience.
• Experience with Design Controls, Verification & Validation, and Risk Management in a regulated industry.
• Strong knowledge of medical device software and quality regulations.

Responsibilities

• Provide Quality Engineering support for new product development, design changes, and OEM projects.
• Lead Design Control, Verification & Validation, and Risk Management activities.
• Develop and review quality plans, validation plans, design documentation, traceability matrices, and risk assessments.
• Ensure compliance with IEC 62304, IEC 60601, IEC 62366, ISO 14971, FDA, and ISO 13485 requirements.
• Analyze quality metrics, identify trends, and drive continuous improvement initiatives.
• Lead root cause investigations, CAPA activities, and problem-solving efforts.
• Partner with R&D, Regulatory Affairs, Manufacturing, and external stakeholders to achieve project and quality objectives.
• Present quality and compliance updates to leadership and project teams.

Skills

Design Controls

Risk Management

Cybersecurity

Software Lifecycle

Education

Bachelor's degree in Engineering

Tools

IEC 62304

IEC 60601

IEC 62366

ISO 14971

Job description

B. Braun Medical Inc. is seeking a Sr Design Assurance Engineer (Software Medical Devices) in Bethlehem, PA.

The role leads quality and compliance activities for embedded and standalone software across product development and commercialization, ensuring adherence to regulatory and customer requirements. The position requires a Bachelor's degree in Engineering and 6+ years of relevant experience, with expertise in Design Controls, V&V, Risk Management, and medical device software regulations.