Sr Design Assurance Engineer (Software Medical Devices)
Company: B. BRAUN MEDICAL (US) INC
Job Posting Location: Bethlehem, Pennsylvania, United States
Functional Area: Quality
Working Model: Hybrid
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 13757
Position SummaryLead 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.
Key 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.
Required 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.
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.
Work Environment- Collaborative, cross-functional environment working with Quality, R&D, Manufacturing, and Regulatory teams.
- Primarily office-based with occasional time spent in laboratory and manufacturing settings.
- Opportunity to influence product quality, patient safety, and innovation in healthcare.
Salary Range: $92,215 - $115,300
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
