Associate Director, Risk Management

B. Braun Melsungen AG; Bethlehem (Northampton County); Hybrid; USD 135,000 - 168,000; 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 strategic Head of Risk Management to lead risk programs for pharmaceutical products, medical devices, and combination products.

This executive role manages risk specialists and applied statisticians, working with global teams to harmonize practices and drive continuous improvement. You will develop and oversee risk management systems, apply advanced statistics, ensure regulatory compliance, and foster a culture of quality and safety across the

Qualifications

• Bachelor's degree in Engineering, Quality, Statistics, Life Sciences, or a related field.
• 6+ years of experience in risk management, quality, reliability, or related discipline.
• Experience leading complex projects and driving continuous improvement.
• Preferred: professional certification in Risk Management, Quality, Reliability, or related field.
• Strong leadership and coaching abilities.

Responsibilities

• Lead and continuously improve risk management systems and processes across the product lifecycle.
• Identify and mitigate product and process risks while promoting a culture of quality and safety.
• Manage and develop a team of Risk Management Specialists and Applied Statisticians.
• Drive the use of risk management and statistical tools to improve product reliability and manufacturing performance.
• Partner with global teams to standardize risk management practices and implement harmonized electronic systems.
• Ensure compliance with ISO 14971 and ICH Q9.

Skills

Leadership

Risk Management

Statistics

Quality Systems

Cross-functional Collaboration

Education

Bachelor's degree in Engineering/Quality/Statistics/Life Sciences

Tools

Statistical Software

Job description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Company: B. BRAUN MEDICAL (US) INC

Job Posting Location: Bethlehem, Pennsylvania, United States

Functional Area: Quality

Working Model: Hybrid

Days of Work: Wednesday, Tuesday, Friday, Thursday, Monday

Shift: 5X8

Relocation Available: No

Requisition ID: 13883

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

B. Braun Medical Inc. is seeking a strategic and experienced Head of Risk Management to lead risk management programs for pharmaceutical products, medical devices, and combination products. This leadership role is responsible for overseeing risk management systems, statistical methodologies, and continuous improvement initiatives that support product quality, patient safety, regulatory compliance, and operational excellence.

The Head of Risk Management will manage a team of risk management specialists and applied statisticians while collaborating with global B. Braun organizations to drive harmonized risk management practices and implement innovative solutions that reduce risk and improve product reliability.

Key Responsibilities

• Lead and continuously improve risk management systems and processes across the product lifecycle.
• Identify and mitigate product and process risks while promoting a culture of quality and safety.
• Manage and develop a team of Risk Management Specialists and Applied Statisticians.
• Drive the use of risk management and statistical tools to improve product reliability and manufacturing performance.
• Partner with global teams to standardize risk management practices and implement harmonized electronic systems.
• Ensure compliance with industry regulations and standards, including ISO 14971 and ICH Q9.

Preferred Skills

• Strong leadership and team development experience.
• Expertise in risk management within pharmaceutical, medical device, or combination product industries.
• Advanced knowledge of statistics, quality systems, and continuous improvement methodologies.
• Experience with usability and cybersecurity risk management.
• Excellent analytical, communication, and cross-functional collaboration skills.

Qualifications

Required:

• Bachelor's degree in Engineering, Quality, Statistics, Life Sciences, or a related field.
• 6+ years of experience in risk management, quality, reliability, engineering, or a related discipline.
• Experience leading complex projects and driving continuous improvement initiatives.

Preferred:

• Professional certification in Risk Management, Quality, Reliability, or related field.
• Experience managing technical or quality-focused teams.

Salary Range: $135,000-$168,000

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, .