Risk and Reliabilty Statistical Specialist

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

Position Summary

We are seeking a Risk and Reliability Statistical Specialist to drive data-driven decision-making across quality, manufacturing, and risk management. This role applies statistical methods to improve product reliability, optimize sampling strategies, and ensure compliance within a regulated environment.

Key Responsibilities

• Apply statistical methods for risk management (ISO 14971), including failure rates and probability analysis
• Develop sampling plans for inspection, validation, and process monitoring
• Perform reliability analysis (Weibull, lognormal, exponential)
• Support process capability, trend analysis, and variation reduction
• Lead/support CAPA investigations using data-driven approaches
• Establish control limits and monitoring strategies
• Remote role with up to 15% travel

Qualifications

• Bachelor’s in Engineering, Statistics, or related technical field
• 5+ years in a regulated manufacturing environment (medical device, pharma, life sciences, healthcare)
• Experience with statistical analysis, sampling, and reliability testing
• Knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820
• Strong analytical, communication, and problem-solving skills required

Preferred

• Advanced degree or training in Statistics/Reliability
• Experience designing statistically justified validation and verification strategies
• Six Sigma, CQE, or Reliability certification

Additional Info

• Other Duties : Responsibilities may change based on business needs.

• Physical Demands: Light work (up to 20 lbs occasionally). Primarily seated with occasional standing, walking, and reaching

• Work Environment: Office setting; moderate noise.

Pay Range- $92,215 - $115,271 /annually

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 .

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 .