Associate Director, Risk Management

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

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:

• Master's degree.
• 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.