Senior Reliability Engineer (Medtech)

TL;DR

Senior Reliability Engineer (Medtech): Leading post-market quality, reliability, and risk management for Targeted Drug Delivery (TDD) products with an accent on evaluating field data and coordinating cross-functional improvements. Focus on translating real-world signals into actionable design changes for hardware, firmware, and software to ensure patient safety.

Location: Onsite in Fridley, MN (4 days a week)

Salary: $107,200.00 - $160,800.00

Company

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

What you will do

• Lead evaluations of field-observed product performance for TDD systems, ensuring alignment with risk management files.
• Analyze complaint trends, software behavior, and hardware performance to identify reliability gaps.
• Partner with Medical Safety to assess harm severity and estimate probability of occurrence for user risk.
• Evaluate the risk impacts of design, manufacturing, and software changes for market-released products.
• Serve as a technical representative for post-market processes, specifically CAPA.
• Collaborate with R&D, Manufacturing, and Regulatory teams to translate field data into product improvements.

Requirements

• Baccalaureate degree with 4+ years of experience, Master's with 2+ years, or a PhD.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Must be able to work onsite 4 days a week in Fridley, MN.
• Ability to travel up to 20% to enhance collaboration and project completion.

Nice to have

• Experience in the medical device field.
• Experience writing technical documentation for regulated industries.
• Proficiency in data analysis methods to evaluate product performance and reliability.
• Experience working with manufacturing and operations teams.

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and FSA options.
• 401(k) plan with employer contribution and matching.
• Tuition assistance and reimbursement programs.
• Paid time off, paid holidays, and a global well-being program (Simple Steps).
• Employee Stock Purchase Plan and various retirement plan supplements.