Statistical Sampling Specialist
Company: B. BRAUN MEDICAL (US) INC
Job Posting Location: Allentown, Pennsylvania, United States, Daytona Beach, Florida, United States, Bethlehem, Pennsylvania, United States, Irvine, California, United States
Functional Area: Quality
Working Model: Remote
Days of Work: Wednesday, Tuesday, Friday, Thursday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 8350
Position SummaryWe 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.
