Senior Design Assurance Engineer: Medical Devices

RXinsider LTD.; Bethlehem (Northampton County); On-site; USD 92,000 - 115,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. is seeking a seasoned Quality Engineer to lead quality and compliance activities for medical device software from concept through commercialization. You will own Design Controls, Risk Management, and cybersecurity efforts while ensuring IEC/FDA/ISO requirements are met.

Join a collaborative team and influence product quality, patient safety, and regulatory submissions across R&D, Regulatory Affairs, and Manufacturing.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 6+ years related experience required.
• Experience with Design Controls, Verification & Validation, and Risk Management within a regulated industry.
• Strong knowledge of medical device software and quality regulations.
• Proven experience with root cause analysis, CAPA, and continuous improvement methodologies.
• 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

Quality engineering

Regulatory knowledge

Leadership

Communication

Problem solving

Education

Bachelor's degree in Engineering

Job description

B. Braun Medical Inc. is seeking a seasoned Quality Engineer to lead quality and compliance activities for medical device software from concept through commercialization. You will own Design Controls, Risk Management, and cybersecurity efforts while ensuring IEC/FDA/ISO requirements are met.

Join a collaborative team and influence product quality, patient safety, and regulatory submissions across R&D, Regulatory Affairs, and Manufacturing.