Reliability Engineer II (Medtech)

TL;DR

Reliability Engineer II (Medtech): Supporting the scaling and improvement of the Affera HW system with an accent on released product engineering and quality response. Focus on designing verification tests, managing risk response, and conducting technical reliability studies to ensure product safety and performance.

Location: Onsite in Mounds View, Minnesota, USA (minimum 4 days a week). Must possess unrestricted U.S. work authorization.

Salary: $84,800 - $127,200

Company

A global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through bold engineering and innovation.

What you will do

• Develop and conduct technical reliability studies and design of experiments (DOE) for engineering concepts.
• Recommend design and test methods, as well as statistical process control procedures, to achieve reliability targets.
• Perform comprehensive risk analysis studies for new designs and processes.
• Compile and analyze performance reports and process control statistics to identify variables affecting product quality.
• Develop reliability engineering programs to meet company, customer, and governmental agency objectives.
• Propose design or formulation changes to enhance overall system and process reliability.

Requirements

• Bachelor's degree with at least 2 years of relevant experience, or a Master's degree.
• Unrestricted U.S. work authorization at the time of hire (sponsorship not available for this level).
• Proficiency in design controls, V&V, and Risk Management for both commercial and development phases.
• Knowledge of 21CFR820, ISO13485, and ISO14971 standards.
• Experience managing Quality Management System (QMS) procedures and processes.

Nice to have

• Direct experience in the Medical Device industry.
• Expertise in system-thinking and process mapping to identify interfaces and dependencies.
• Proven ability in stakeholder management and coordinating complex assignments with cross-functional teams.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and Healthcare FSA.
• 401(k) plan with employer contribution and match.
• Short-term incentive plan (hirify.global Incentive Plan - MIP).
• Paid time off, paid holidays, and an Employee Stock Purchase Plan.
• Tuition assistance/reimbursement and the Simple Steps global well-being program.
• Collaborative onsite culture with a focus on professional growth and cross-functional interaction.