What are the responsibilities and job description for the Risk & Reliability Statistical Specialist position at B. Braun Medical Inc. (US)?
Company Description B. Braun Medical Inc. is a leading provider of infusion therapy, pain management, and related medical products and services for the healthcare industry. The company’s portfolio also includes solutions for clinical nutrition, pharmacy admixture, and dialysis, with a strong focus on preventing treatment errors and enhancing patient, clinician, and environmental safety. Headquartered in Bethlehem, PA, B. Braun Medical Inc. is part of the B. Braun Group of Companies in the U.S., alongside B. Braun Interventional Systems, Aesculap®, and CAPS®. Globally, the B. Braun Group employs more than 64,000 team members in 64 countries and is guided by its Sharing Expertise® philosophy, emphasizing collaboration with customers and clinicians to improve care and reduce costs. Candidates joining B. Braun can expect a mission-driven environment committed to innovation, quality, and continuous improvement in healthcare.
Role Description The Risk & Reliability Statistical Specialist is a full-time, on-site role based in Irvine, CA. This role is responsible for applying statistical methods and reliability engineering principles to support product design, manufacturing, and post-market activities for medical devices and related products. Day-to-day responsibilities include designing and analyzing experiments, conducting reliability and life data analyses, developing statistical models for risk assessment, and contributing to Failure Modes and Effects Analysis (FMEA) and other risk management documents. The specialist collaborates closely with cross-functional teams such as R&D, Quality, Regulatory Affairs, Manufacturing, and Clinical to interpret data, identify trends, and recommend actions that enhance product safety, quality, and performance. Additional tasks may include creating and maintaining statistical tools and templates, preparing technical reports and presentations for internal stakeholders and regulators, and providing training or guidance to colleagues on statistical and reliability best practices.
Qualifications
Role Description The Risk & Reliability Statistical Specialist is a full-time, on-site role based in Irvine, CA. This role is responsible for applying statistical methods and reliability engineering principles to support product design, manufacturing, and post-market activities for medical devices and related products. Day-to-day responsibilities include designing and analyzing experiments, conducting reliability and life data analyses, developing statistical models for risk assessment, and contributing to Failure Modes and Effects Analysis (FMEA) and other risk management documents. The specialist collaborates closely with cross-functional teams such as R&D, Quality, Regulatory Affairs, Manufacturing, and Clinical to interpret data, identify trends, and recommend actions that enhance product safety, quality, and performance. Additional tasks may include creating and maintaining statistical tools and templates, preparing technical reports and presentations for internal stakeholders and regulators, and providing training or guidance to colleagues on statistical and reliability best practices.
Qualifications
- Strong statistical analysis skills, including experimental design (DOE), hypothesis testing, regression, capability analysis, and statistical modeling.
- Experience with reliability engineering methods such as life data analysis (e.g., Weibull), accelerated life testing, reliability growth, and risk assessment tools (e.g., FMEA, fault tree analysis).
- Proficiency with statistical software (e.g., Minitab, JMP, R, or similar) and solid skills in Excel and data visualization tools for reporting and dashboards.
- Knowledge of medical device or pharmaceutical quality systems, including risk management and regulatory expectations (e.g., ISO 14971, ISO 13485, FDA guidelines), is strongly preferred.
- Excellent analytical, problem-solving, and critical-thinking abilities, with attention to detail and sound documentation practices.
- Effective communication and collaboration skills, with the ability to explain complex statistical concepts to non-specialist stakeholders and work in cross-functional teams. <