Senior Reliability Engineer (Hardware)

TL;DR

Senior Reliability Engineer (Hardware): Supporting the scaling and improvement of the Affera Mapping and Ablation System with an accent on reliability studies, risk analysis, and design of experiments. Focus on ensuring product reliability for next-generation ablation generators through rigorous statistical analysis and cross-functional collaboration.

Location: Must be based in Mounds View, Minnesota, USA. The role requires onsite presence at least 4 days per week.

Salary: $107,200 – $160,800 USD

Company

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

What you will do

• Conduct technical reliability studies and design of experiments (DOE) for hardware engineering concepts.
• Perform comprehensive risk analysis for new designs and manufacturing processes.
• Analyze performance reports and process control statistics to identify and mitigate failure risks.
• Develop reliability engineering programs to meet company and governmental objectives.
• Collaborate with cross-functional teams on change management and risk response for the Affera hardware portfolio.
• Propose design or formulation changes to improve system reliability and performance.

Requirements

• Bachelor’s degree with 4+ years of experience, Master’s with 2+ years, or PhD with 0 years of relevant experience.
• Must possess unrestricted U.S. work authorization (sponsorship is not provided for this level).
• Strong understanding of design controls, V&V, and Risk Management.
• Experience with 21CFR820, ISO13485, and ISO14971 standards.
• Demonstrated ability in stakeholder management and coordinating complex assignments.
• Experience in the medical device or electrical/electronic hardware industry.

Culture & Benefits

• Competitive salary and short-term incentive plans (MIP).
• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Flexible spending accounts (HSA/FSA) and life insurance.
• Tuition assistance and reimbursement programs.
• Global well-being programs and paid time off.