Lead Medical Device Design Assurance & Cybersecurity

B. BRAUN MEDICAL (US) INC; 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 Lead Quality Engineer to oversee the development and compliance of innovative medical devices with embedded and standalone software.

You will spearhead Design Controls, Risk Management, Human Factors, and Cybersecurity efforts, ensuring IEC 62304/60601 and ISO 14971 alignment across concept to commercialization; collaboration with R&D, Regulatory, Manufacturing and external partners is essential.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 6+ years of relevant experience in quality/regulatory environment.
• Experience with design controls, verification & validation, and risk management.
• Strong knowledge of medical device software and quality regulations.
• Proven root cause analysis and CAPA experience.
• Excellent communication, collaboration, and leadership skills.

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

Medical device software knowledge

Quality regulations

Root cause analysis

CAPA

Communication skills

Leadership

Education

Bachelor's degree in Engineering or related technical discipline

Tools

IEC 62304

IEC 60601

IEC 62366

ISO 14971

ASQ CQE

CSQE

Job description

B. Braun Medical, Inc. in Bethlehem, PA, is seeking a Lead Quality Engineer to oversee the development and compliance of innovative medical devices with embedded and standalone software.

You will spearhead Design Controls, Risk Management, Human Factors, and Cybersecurity efforts, ensuring IEC 62304/60601 and ISO 14971 alignment across concept to commercialization; collaboration with R&D, Regulatory, Manufacturing and external partners is essential.