Pre-Market Software Reliability Engineering Manager (Medtech)

TL;DR

Pre-Market Software Reliability Engineering Manager (Medtech): Ensuring medical devices exceed safety and reliability requirements by leading a team of reliability and safety engineers with an accent on Design for Reliability (DfR) and risk reviews. Focus on managing R&D project budgets, mentoring technical staff, and ensuring compliance with QMS deliverables.

Location: On-site 4 days per week in Mounds View, MN, USA

Salary: $142,400 - $213,600 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical technologies.

What you will do

• Lead a team of pre-market software reliability, safety, and supplier quality engineers within the CRM unit.
• Provide leadership for Design for Reliability (DfR) and provide technical guidance on reliability, safety, and quality.
• Manage direct and dotted-line reports, including budget, resource, and project management.
• Recruit, hire, and onboard new team resources while coaching and mentoring staff performance.
• Work cross-functionally with project teams to plan R&D budgets and staff allocation.
• Review team deliverables and provide management review of QMS deliverables.

Requirements

• Bachelor’s degree in STEM and minimum 7 years of technical work experience OR an advanced STEM degree with 5 years technical and 5 years managerial experience.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Proven experience in software reliability engineering leadership within R&D.
• Ability to manage annual expense and operating budgets.

Nice to have

• CRE (Certified Reliability Engineer) or CSQE (Certified Software Quality Engineer) certifications.
• Experience with software FMEA, FTA, and reliability growth models.
• Knowledge of medical device standards: IEC 62304, ISO 13485, and ISO 14971.
• Experience with DFSS, DFLS, DRM, or other robust design practices.
• Proficiency with DevOps processes and Agile or behavior-based development.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and Healthcare FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and short-term disability leave.
• Employee Stock Purchase Plan and tuition assistance/reimbursement.
• Global well-being program (Simple Steps) and Employee Assistance Program.