Risk and Reliability Statistical Specialist (MedTech)

TL;DR

Risk and Reliability Statistical Specialist (MedTech): Driving data-driven decision-making across quality, manufacturing, and risk management with an accent on statistical methods to improve product reliability. Focus on performing reliability analysis, optimizing sampling strategies, and ensuring regulatory compliance within FDA and ISO environments.

Location: Remote (USA) with up to 15% travel

Salary: $92,215 - $115,271 annually

Company

hirify.global Medical Inc. is a leader in infusion therapy and pain management, developing and manufacturing innovative medical products for the healthcare industry.

What you will do

• 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 using Weibull, lognormal, and exponential distributions.
• Support process capability, trend analysis, and variation reduction.
• Lead and support CAPA investigations using data-driven approaches.
• Establish control limits and monitoring strategies.

Requirements

• Bachelor’s degree in Engineering, Statistics, or a related technical field.
• 5+ years of experience in a regulated manufacturing environment (medical device, pharma, life sciences, or healthcare).
• Experience with statistical analysis, sampling, and reliability testing.
• Knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820.
• Must be based in the United States.

Nice to have

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

Culture & Benefits

• Comprehensive healthcare package.
• 401(k) retirement plan.
• Tuition reimbursement.
• Remote work flexibility.