Quality Engineer II

A Day in the Life

Required Qualifications

• Bachelor's degree in Mechanical Engineering with 5+ years of overall experience, including 3+ years of quality engineering experience in medical device, regulated manufacturing, or healthcare industries.
• Experience with medical device Design Controls, Risk Management, and product development activities.
• Experience supporting ISO 14971 risk management activities, including Risk Management Plans, Hazard Analyses, and Design Failure Mode and Effects Analysis (DFMEA).
• Knowledge of FDA Quality System Regulation, ISO 13485, EU MDR, IEC 60601, 21 CFR Part 820, and 21 CFR Part 11.
• Experience using statistical tools and methodologies, including Minitab, sampling plans, hypothesis testing, Analysis of Variance (ANOVA), Gauge Repeatability and Reproducibility (GR&R), and related statistical techniques.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), or Certified Reliability Engineer (CRE) certification.
• ISO 9001 or ISO 13485 Internal Auditor or Lead Auditor certification.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with DMAIC or Design for Six Sigma (DFSS)/DMADV methodologies.
• Experience acting as a Risk Management or Design Quality subject matter expert within cross-functional product development teams.
• Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
• Recruitment Fraud Alert
• We are aware of phishing scams targeting job seekers. Please keep the following in mind:
• Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
• Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
• If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
• If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected].
• Physical Job Requirements
• The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
• Benefits & Compensation
• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Benefits & Compensation