Pre-Market Software Reliability Engineering Manager (Medtech)

TL;DR

Pre-Market Software Reliability Engineering Manager (Medtech): Leading a team of reliability, safety, and supplier quality engineers to ensure medical device software exceeds safety and reliability standards with an accent on Design for Reliability (DfR) and cross-functional R&D leadership. Focus on managing team performance, budget oversight, and ensuring compliance with medical device regulations in a high-stakes, collaborative environment.

Location: Must be based in Mounds View, MN; on-site 4 days per week.

Salary: $150,400–$225,600 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Lead and mentor a team of pre-market software reliability, safety, and supplier quality engineers.
• Provide leadership for Design for Reliability (DfR) and contribute to development activities within R&D project teams.
• Manage annual expense budgets, resource allocation, and project planning.
• Ensure compliance with QMS deliverables and provide management review of technical documentation.
• Collaborate cross-functionally to define initiatives that improve team capabilities and operational efficiency.
• Recruit, hire, and onboard new talent while managing individual performance and development plans.

Requirements

• Bachelor’s degree in STEM field with 7+ years of technical experience OR advanced degree with 5+ years of technical and 5+ years of managerial experience.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Ability to work on-site in Mounds View, MN, 4 days per week.
• Demonstrated success in project management and influence management.
• Experience in managing budgets and cross-functional team resources.

Nice to have

• Certified Reliability Engineer (CRE) or Certified Software Quality Engineer (CSQE).
• Experience with IEC 62304, ISO 13485, and ISO 14971 standards.
• Background in medical devices or other highly regulated industries.
• Knowledge of Design for Six Sigma (DFSS) or Design for Reliability and Manufacturability (DRM).
• Experience with software fault-tolerant design and reliability growth models.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA/FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and short-term/long-term disability leave.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and well-being programs.