Position Description:
Sr. Reliability Engineer for Medtronic, Inc., located in Brooklyn Center, MN. Provide reliability engineering support to new product development and continuous improvement of commercially released medical devices. Responsible for technical assessments and compliance activities to ensure that reliability and safety are proactively designed into our products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. Upgrade legacy test systems, developing comprehensive work instructions and tools to streamline the transition to new systems for both engineering and technician teams. Provide support in assessing the impact of post commercialization changes to products. Responsible for hardware and software development and qualification for automated battery testing equipment. Conduct electrical performance testing of primary and rechargeable batteries in implantable medical devices. Perform comprehensive risk mgmt. activities, including Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), and Root Cause Analysis. Handle post-market product complaints, failure investigations, Non-Conforming Material Records (NCMR), and Corrective Action Preventative Actions (CAPA). Characterize process reliability using Gage R & R, Variable and Attribute Test Method Validation, Confidence and Tolerance Limits studies, and Capability & Normality Assessments, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Develop Statistical Process Control (SPC) charts and Out of Control Action Plans (OCAP) for critical processes. Generate deliverables for pre-market product development, including Product Performance Specifications, Design Verification and Validation, Design Transfer, and Usability and Human Factor Engineering. Perform data analysis and reporting using T-test, ANOVA, regression modeling, hypothesis testing, and Design of Experiments (DOE) tools in JMP, Minitab, R, or Python. Manage SQL/MongoDB database queries for battery performance testing in customized repositories. Ensure compliance with medical device regulations, including FDA 21 CFR 820, ISO 13485, ISO 9001, and ISO 14971. #LI-DNI
Basic Qualifications:
Master’s Degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, or Biomedical Engineering or related engineering field and two (2) years of experience as a manufacturing or reliability engineer. Must possess at least two (2) years’ experience with each of the following: Electrical performance testing of batteries in implantable medical devices; Hardware and software development and qualification for automated battery testing equipment; Risk mgmt., Design and Process FMEA, and Root Cause Analysis; Post-market product complaints, failure investigations, NCMR, and CAPA; Characterize process reliability using Gage R & R, Variable and Attribute Test Method Validation, Confidence and Tolerance Limits studies, and Capability & Normality Assessments, and IQ/OQ/PQ; SPC charts and OCAP; Pre-market product development, including Product Performance Specifications, Design Verification and Validation, Design Transfer, and Usability and Human Factor Engineering; T-test, ANOVA, regression modeling, DOE tools in JMP/Minitab, and R/ Python; SQL/MongoDB database queries; and FDA 21 CFR 820, ISO 13485, ISO 9001, and ISO 14971.
Salary: $108,000 to $159,600 per year
#LI-DNI
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below: Medtronic benefits and compensation plans
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What We Do
Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions.
Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year.
To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.
