Reliability Engineer II
Medtronic
Summary
In this role as a Reliability Engineer II supporting new product development, you will provide technical leadership across all quality aspects of reliability for product design within Cardiac Ablation Solutions. You will serve as a key partner to cross functional teams, guiding critical quality decisions that protect patients and ensure successful product launch. This position is located in Mounds View, MN within Electrophysiology Therapies and requires 4 days onsite per week.
Job description
Responsibilities
- Design Control: Assess new component and product designs for potential risk impacts, including requirement reviews, drawing reviews, BOM reviews. Generate, review, and approve design FMEA. Create design verification protocols and test reports in compliance with medical device design control procedures.
- Design for Reliability: Collaborate with cross functional teams to resolve technical issues. Execute testing and analyze reliability data from design characterization to identify and resolve potential issues with components, interfaces, and product systems.
- Test Method Development: Create new test methods based on product requirements, order equipment, design fixtures, execute test method validation, and release work instructions and TMV reports.
- Risk Management: Support risk assessments and hazard analyses based on predicate product and post-market data. Update Risk Management files for design and manufacturing issues.
- Root Cause Investigation: Lead investigations into product failures, utilizing root cause analysis techniques to determine underlying causes. Implement technical learnings into improved product design and risk management.
- Continuous Improvement: Collaborate with design, manufacturing, and quality teams to implement design, process or supplier changes, corrective and preventive actions that enhance product reliability.
- Critical Thinking: Determine the need for further action or to document defendable rationales while understanding impact to the product, patient, and program. Demonstrate strong written and verbal communication skills. Works well with others and is able to resolve conflicts.
- Design Transfer: Support Supplier Quality and Manufacturing teams in risk based decisions for supplier selection, Quality Impact Assessment, test methods, including knowledge transfer to post-market Quality, Returned Products Analysis, and Complaints Trending.
Must Have: Minimum Requirements
- Requires a Baccalaureate degree in Science, Technology, Engineering, Math.
- Minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
Nice to Have
- Prior experience in the medical device industry across product development, operations, or quality functions
- Demonstrated expertise in risk management in accordance with ISO 14971
- Strong technical writing and communication skills, with the ability to clearly explain complex technical topics to non-technical audiences
- Proven ability to lead root cause investigations, solve complex technical problems, and perform statistical data analysis
- Knowledge of Microsoft Office Applications (Word, Excel, and PowerPoint) and Windows OS
- Familiarity with ISO 13485, 60601, GD&T
Requirements
- Baccalaureate degree in Science, Technology, Engineering, Math
- Minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience
- Unrestricted U.S. work authorization at time of hire and for duration of employment
- Prior experience in the medical device industry across product development, operations, or quality functions
- Demonstrated expertise in risk management in accordance with ISO 14971
- Strong technical writing and communication skills
- Proven ability to lead root cause investigations and solve complex technical problems
- Perform statistical data analysis
- Knowledge of Microsoft Office Applications (Word, Excel, PowerPoint) and Windows OS
- Familiarity with ISO 13485, 60601, GD&T
Benefits
- Health, Dental & Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- 401(k) Matching
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Incentive Plans
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.