Reliability Engineer II

About the Role

The Reliability Engineer II ensures the safety, reliability, and performance of products throughout the product lifecycle. This role partners cross-functionally with Design, Quality, Manufacturing, Regulatory, Supplier Quality, and Operations teams to identify and mitigate reliability risks, execute reliability assessments, and drive improvements that enhance patient outcomes and product performance.

Responsibilities

• Lead and support reliability activities for new product development and sustaining engineering projects.
• Develop and execute reliability strategies, plans, and test protocols aligned with product requirements and regulatory expectations.
• Conduct reliability analyses, including:
  • Fault Tree Analysis (FTA)
  • Failure Modes and Effects Analysis (FMEA)
  • Design of Experiments (DOE)
  • Statistical data analysis
• Support cross-functional projects and programs, including pacemakers and leads.
• Collaborate with cross-functional teams to investigate failures, conduct root cause analyses, and implement corrective and preventive actions.
• Support Design Verification, Design Validation, and Design for Reliability (DfR) activities.
• Develop accelerated life testing and environmental stress testing methodologies.
• Evaluate supplier and manufacturing process reliability and identify areas for improvement.
• Prepare technical reports, presentations, and recommendations for management and project teams.
• Support regulatory submissions, audits, and compliance activities as required.
• Contribute to continuous improvement initiatives that enhance product quality, reliability, and operational efficiency.
• Mentor junior engineers and provide technical guidance on reliability methodologies and best practices.
• Support manufacturing sites and work cross-functionally to complete deliverables.

Requirements

• Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, Industrial, Packaging, or related field).
• 1-5 years of engineering experience, including experience in reliability, quality, manufacturing, or product development.
• Experience applying statistical analysis techniques and reliability engineering principles.
• Knowledge of risk management and failure analysis methodologies.
• Strong problem-solving and analytical skills, particularly in medical device or manufacturing support contexts.
• Effective communication and collaboration skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications

• Experience in the medical device, pharmaceutical, aerospace, automotive, or other highly regulated industry.
• Knowledge of FDA, ISO 13485, IEC 60601, ISO 14971, or other applicable industry standards.
• Experience with Minitab, JMP, ReliaSoft, MATLAB, or similar statistical/reliability software tools.
• Experience leading cross-functional investigations and risk reduction initiatives.

Key Competencies

• Reliability Engineering
• Statistical Analysis
• Failure Analysis
• Risk Management
• Root Cause Investigation
• Design for Reliability
• Project Management
• Technical Communication
• Cross-Functional Collaboration
• Continuous Improvement