Reliability Engineer (Medtech)

TL;DR

Reliability Engineer (Medtech): Ensuring the performance, reliability, and safety of neurovascular medical devices with an accent on test plan execution, risk analysis, and statistical data modeling. Focus on collaborating with R&D and manufacturing teams to mitigate risks and drive continuous improvement in a highly regulated environment.

Location: Must be based in Irvine, CA (Onsite 4 days/week)

Salary: $69,600 – $104,400

Company

A global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Develop and conduct technical reliability studies and design of experiments (DOE).
• Perform risk analysis for new designs and manufacturing processes.
• Analyze performance reports and process control statistics to identify variables affecting product quality.
• Partner with R&D, Clinical, and Regulatory teams to mitigate risks across the product lifecycle.
• Support root cause investigations and recommend design improvements.
• Ensure corrective measures meet governmental and company reliability standards.

Requirements

• Bachelor’s degree in engineering or related discipline.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Ability to work onsite in Irvine, CA at least 4 days per week.
• Strong analytical skills with proficiency in data analysis and statistical methods.
• Ability to collaborate effectively in a cross-functional, highly regulated environment.

Nice to have

• Experience in neurovascular or vascular medical device development.
• Knowledge of Class III medical device regulations.
• Proficiency in FMEA, fault tree analysis, and statistical process control (SPC).

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and well-being programs.