Sr. Reliability Engineer
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Job Location:
Brooklyn Center, MN - USA
Yearly Salary:
$ 108000 - 159600
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
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:
Masters 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: $108000 to $159600 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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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
Required Experience:
Senior IC
Key Skills
- Kubernetes
- FMEA
- Continuous Improvement
- Elasticsearch
- Go
- Root cause Analysis
- Maximo
- CMMS
- Maintenance
- Mechanical Engineering
- Manufacturing
- Troubleshooting
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
