Sr. Reliability Engineer (Medical Devices)

TL;DR

Sr. Reliability Engineer (Medical Devices): Providing reliability engineering support for the new product development lifecycle of medical devices with an accent on risk management architecture and Design for Reliability and Manufacturability (DRM) targets. Focus on navigating complex government regulations, conducting software system evaluations, and utilizing statistical analysis tools to improve device performance.

Location: Hybrid (onsite at least 4 days per week in Brooklyn Park, MN)

Salary: $106,400–$159,600 per year

Company

hirify.global is a global leader in medical technology, developing innovative healthcare solutions to alleviate pain, restore health, and extend life.

What you will do

• Support the new product development lifecycle for medical devices, focusing on risk management and DRM targets.
• Execute design transfer for software and hardware, including design and phase reviews.
• Conduct detailed evaluations of software systems, including requirements, integration, verification, and validation.
• Ensure strict compliance with 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971, and IEC 62304.
• Support pre-market teams with complaint prediction and predictive field performance.
• Perform statistical data analysis using ANOVA, Gage R&R, Attribute Agreement Analysis, and Test Method Validation (TMV).

Requirements

• Master’s degree in Mechanical, Industrial, Biomedical Engineering, or a related field.
• At least 2 years of experience as a manufacturing, systems, or reliability engineer specifically for medical devices.
• Must be based in or able to work onsite at least 4 days per week in Brooklyn Park, MN.
• Proven experience with 21 CFR Part 820 QSR, ISO 13485, EU MDR, ISO 14971, and IEC 62304.
• Proficiency in ANOVA, Gage R&R, and TMV.
• Experience with MS Office Suite, Prochain, Requs AI Predict, Agile, and Minitab.

Culture & Benefits

• 401(k) plan with employer contribution and match.
• Incentive plans and Employee Stock Purchase Plan.
• Comprehensive paid time off and paid holidays.
• Short-term disability and Employee Assistance Program.
• Non-qualified Retirement Plan Supplement for eligible seniority levels.