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. 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. Globally, the B. Braun Group employs more than 64,000 employees in 64 countries.

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.

Requirements

• 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

Preferred Qualifications

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

Additional Information

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

$92,215 - $115,271 annually. The targeted range for this role takes into account factors such as skill sets, experience, training, licensure, certifications, and business needs. The disclosed range has not been adjusted for geographic differentials.

Benefits

• Healthcare
• 401(k) plan
• Tuition reimbursement