We are for an experienced Reliability & Statistical Engineer with medical device risk management (14971) expertise to provide technical leadership in statistical analysis, product reliability, risk management, and quality engineering for complex regulated products. This position plays a key role in improving product reliability, supporting manufacturing and quality initiatives, and driving data-based decision making throughout the product lifecycle.
This is an excellent opportunity for an engineer who enjoys solving complex problems using statistics, reliability engineering, and risk analysis within a highly regulated medical device or life sciences environment.
As the Reliability & Statistical Engineer, you will serve as the statistical subject matter expert supporting engineering, manufacturing, quality, and regulatory teams.
Responsibilities include:
- Perform statistical analyses to support product development, manufacturing, validation, and quality improvement initiatives.
- Develop statistically justified sampling plans for incoming inspection, process validation, verification testing, and routine quality monitoring.
- Conduct reliability analyses using Weibull, Lognormal, Exponential, and related life data models.
- Analyze product failure rates, field performance, and reliability trends to identify opportunities for improvement.
- Apply statistical methods to support Risk Management activities in accordance with ISO 14971.
- Support Design Verification, Process Validation (IQ/OQ/PQ), Manufacturing Validation, and continuous improvement initiatives.
- Perform process capability studies, SPC analysis, trend analysis, control chart development, and variation reduction.
- Establish statistical monitoring strategies and control limits for manufacturing processes.
- Support root cause investigations, CAPA, nonconformance investigations, and risk assessments using data-driven methodologies.
- Partner with cross-functional teams including Quality, Manufacturing, R&D, Regulatory Affairs, and Operations.
- Present technical analyses and recommendations to engineering and management teams.
- Ensure statistical methodologies comply with FDA Quality System Regulations and applicable international standards.
Required Qualifications
- Bachelor's degree in Engineering, Statistics, Mathematics, Applied Statistics, Industrial Engineering, Quality Engineering, or related technical discipline.
- 5+ years of experience in a regulated manufacturing environment.
- Experience within Medical Device, Pharmaceutical, Biotechnology, Diagnostics, Healthcare, or other FDA-regulated industries.
- Strong background in statistical analysis and reliability engineering.
- Experience with:
- Reliability analysis
- Weibull analysis
- Probability distributions
- Sampling plans
- Process capability studies (Cp/Cpk/Ppk)
- Statistical Process Control (SPC)
- Trend analysis
- Risk analysis
- Working knowledge of:
- ISO 14971
- ISO 13485
- FDA 21 CFR Part 820 (or QMSR)
- Design Controls
- CAPA
- Validation methodologies
- Strong analytical, communication, and technical problem-solving skills.
Preferred Qualifications
- Master's degree in Statistics, Reliability Engineering, Industrial Engineering, or related field.
- Experience supporting Design Verification, Process Validation, or Manufacturing Validation using statistical methods.
- Experience with Minitab, JMP, SAS, R, Python, or similar statistical software.
- Knowledge of Design of Experiments (DOE).
- Six Sigma Green Belt or Black Belt.
- ASQ Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or equivalent certification.
- Experience developing statistically justified validation protocols and sampling strategies.
Medical Device Reliability Engineering Statistics Statistical Analysis Weibull Minitab JMP DOE SPC Process Capability Cp Cpk Ppk Sampling Plans Validation IQ/OQ/PQ Design Verification CAPA Root Cause Analysis Risk Management ISO 14971 ISO 13485 FDA 21 CFR Part 820 Quality Engineering Manufacturing Engineering Life Sciences Biotechnology Pharmaceutical Process Improvement Continuous Improvement
Pay: $30.00 - $60.00 per hour
Work Location: Remote
