TL;DR

Reliability Engineer II (Medtech): Developing, managing, and executing QMS procedure re-writes to harmonize CAS Design Control procedures with an accent on technical reliability studies, risk analysis, and process control. Focus on improving system and/or process reliability within a medical device context.

Location: Onsite in Mounds View, Minnesota, United States of America, requiring a minimum of 4 days a week in the office.

Salary: $84,000.00 – $126,000.00 USD

Company

%hirify_global% leads global healthcare technology, focusing on alleviating pain, restoring health, and extending life with a team of 95,000+ passionate people.

What you will do

Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and DOEs.
Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
Complete risk analysis studies of new design and processes.
Compile and analyze performance reports and process control statistics, investigating relevant variables.
Ensure that corrective measures meet acceptable reliability standards.
Propose changes in design or formulation to improve system and/or process reliability.

Requirements

Baccalaureate degree with a minimum of 2 years of relevant experience OR a Master's degree with 0 years of relevant experience.
English: B2 required

Nice to have

Medical device experience.
Understanding and experience in design controls, V&V, and Risk Management (commercial and development).
System-thinking and process mapping abilities.
Understanding of 21CFR820, ISO13485, and ISO14971 standards.
Experience managing a QMS procedure/process.

Culture & Benefits

Competitive salary and flexible benefits package.
Health, Dental, and vision insurance, Health Savings Account, and Healthcare Flexible Spending Account.
Life insurance, Long-term disability leave, and Dependent daycare spending account.
Tuition assistance/reimbursement and a global well-being program (Simple Steps).
Incentive plans, 401(k) plan plus employer contribution and match.
Paid time off, paid holidays, and an Employee Stock Purchase Plan.