Sr Design Assurance Engineer (Software Medical Devices)

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.

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

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

Position Summary

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.

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.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Equal employment opportunity, including veterans and individuals with disabilities.

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