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# Sr Design Assurance Engineer (Software Medical Devices)

- **Company:** B. Braun Group
- **Location:** Allentown, PA, United States
- **Experience:** Expert
- **Salary:** $92,215.0 - $115,300.0
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Cyber Security, Software Engineering
- **Published:** September 5, 2026
- **Apply:** https://www.healthjobsnationwide.com/node/15479107/apply-external

## About the Role

* 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.

Preferred Skills

 * Expertise in medical device software development and cybersecurity.
 * Hands-on experience with IEC 62304, IEC 60601, IEC 62366, and ISO 14971.
 * ASQ CQE, CSQE, or other relevant quality certifications.
 * Experience supporting global product development teams and regulatory submissions.
 * Strong project leadership and cross-functional influencing skills.

## Description

Lead quality and compliance activities for the development of innovative medical devices with embedded and standalone software. Serve as a subject matter expert in Design Controls, Risk Management, Human Factors, Software Lifecycle Processes, and Cybersecurity, ensuring products meet regulatory, quality, and customer requirements from concept through commercialization., * 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.


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