Reliability Engineer II (Medtech)

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.