Senior Design Assurance Engineer Medical Device Software

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

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. in Bethlehem, PA, is seeking a Sr Design Assurance Engineer (Software Medical Devices) to lead quality activities from concept through commercialization.

The role emphasizes Design Controls, risk management, and cybersecurity to ensure regulatory, quality, and customer requirements are met. The candidate will collaborate with R&D, Regulatory, Manufacturing, and external partners to drive CAPA, design reviews, and validation activities, while aligning with IEC and FDA

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 6+ years of related experience.
• Experience with Design Controls, Verification & Validation, and Risk Management within 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

Verification & Validation

Risk Management

Cybersecurity

Software Medical Devices

Education

Bachelor's degree in Engineering

Job description

B. Braun Medical Inc. in Bethlehem, PA, is seeking a Sr Design Assurance Engineer (Software Medical Devices) to lead quality activities from concept through commercialization.

The role emphasizes Design Controls, risk management, and cybersecurity to ensure regulatory, quality, and customer requirements are met. The candidate will collaborate with R&D, Regulatory, Manufacturing, and external partners to drive CAPA, design reviews, and validation activities, while aligning with IEC and FDA