Sr Reliability Engineer (Medical Devices)

Location: North Haven, Connecticut, United States

Salary: $107,200–$160,800 annually, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops medical technologies, services, and solutions focused on alleviating pain, restoring health, and extending life.

What you will do

• Provide mechanical and electrical reliability engineering expertise within cross-functional new product development teams.
• Develop reliability plans and identify activities needed to meet company, customer, and agency reliability objectives.
• Plan and perform HALT, ALT, discovery, validation, and verification testing, including test protocols and final reports.
• Collaborate with R&D on test design, material and component selection, electrical and thermal derating, and early identification of design weaknesses.
• Perform reliability predictions, modeling, statistical analysis, and product risk assessments.
• Support post-market reliability analysis and maintain compliant technical documentation throughout the product lifecycle.

Requirements

• Bachelor’s degree in Mechanical, Electrical, Reliability Engineering, or a similar engineering field with at least 4 years of reliability engineering experience; or a master’s degree with at least 2 years of experience; or a PhD with no required relevant experience.
• Experience with reliability engineering, quality management systems, risk management, regulatory compliance, and statistics.
• Knowledge of FDA requirements and applicable ISO/IEC standards, including ISO 14971, ISO 13485, IEC 62304, FDA Part 820, and IEC 60601.
• Strong analytical, problem-solving, root cause analysis, written communication, and cross-functional collaboration skills.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below Principal level.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• ASQ Certified Reliability Engineer, Six Sigma Green Belt, AAMI design control, or equivalent certification.
• Medical device, automotive, or aerospace industry experience.
• Experience with ReliaSoft, LabVIEW, or Sherlock.
• Leadership, project management, mentoring, or software reliability experience.

Culture & Benefits

• Purpose-driven work developing technologies intended to improve patient health.
• Health, dental, and vision insurance, plus Health Savings and Flexible Spending Accounts for eligible regular employees.
• Life insurance, disability coverage, paid time off, and paid holidays.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance, dependent daycare spending account, employee assistance, and global well-being resources.