Remote Risk & Reliability Statistical Specialist

B. Braun Melsungen AG; Allentown, Northern (Lehigh County, KY); Hybrid; USD 92,000 - 115,000; Full time

Job summary

B. Braun Medical Inc. in Allentown, PA, seeks a Principal Statistical Sampling Specialist to drive data-driven decisions across quality, manufacturing, and risk management. The role focuses on reliability, sampling strategies, and regulatory compliance in a remote-capable environment.

The position requires 5+ years in regulated manufacturing, strong analytical skills, and knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820. Up to 15% travel may be required.

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.

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.

Skills

Statistical analysis

Risk management

Data-driven decision making

Problem-solving

Communication

Education

Bachelor’s in Engineering, Statistics, or related technical field

Job description

B. Braun Medical Inc. in Allentown, PA, seeks a Principal Statistical Sampling Specialist to drive data-driven decisions across quality, manufacturing, and risk management. The role focuses on reliability, sampling strategies, and regulatory compliance in a remote-capable environment.

The position requires 5+ years in regulated manufacturing, strong analytical skills, and knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820. Up to 15% travel may be required.