Sr. Quality Engineer

Medtronic•Brooklyn Park, MN

9h•$109,000 - $145,200•Onsite

About The Position

Sr. Quality Engineer for Medtronic, Inc located in Brooklyn Park, MN. Responsible for developing and maintaining quality standards for processing materials, collaborating with engineering and manufacturing teams, and implementing process improvements. The position also includes conducting quality assurance tests, performing statistical analysis, and ensuring corrective measures meet reliability standards. Responsible for technical assessments and compliance activities to ensure that reliability and safety is proactively designed into our products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. Perform Risk Mgmt. Deliverables to include Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis. Support Design and Process Control deliverables to include Product Performance Specifications, Design Verification, Design Validation, approve product drawings/prints, Process Characterization and Process Validation. Provide support for Variable and Attribute Test Method Development and Validation. Provide support for Complaint and Product Failure Investigations, post market root cause analysis, Corrective and Preventive Actions (CAPA) and Non- Conforming Material Requests (NCMR). Navigate government and quality regulations to include FDA 21 CFR part 820 and part 211 requirements and ISO 13485, ISO 9001 and ISO 14971. Utilize statistical tools and software to include Design of Experiments (DOE), ANOVA, Confidence and Tolerance Limits, Gage R&R, Capability analysis and Six Sigma Methodology in auditing and ensuring quality outcomes. Provide specialized knowledge in the manufacturing process of Coating of medical devices for perfusion systems including Biocompatible coatings with and without Active Pharmaceutical ingredients (API), manufacturing of combination products. Coordinate Control Environment Area (CEA) Validations, Control Environment Area Excursion Analysis and investigation and utilize computer and software packages to include MS Office Suite, MS Project, MS Access, Minitab and SAP. #LI-DNI.

Requirements

Bachelors’ Degree or foreign equivalent in Nanotechnology, Mechanical, Industrial, Chemical or Biomedical Engineering or related engineering field.
Requires four (4) years’ experience in Quality Engineer for Medical devices.
Must possess at least four (4) years’ experience in each of the following: Risk Mgmt. Deliverables to include Process FMEA and Product Hazard Analysis; Variable and Attribute Test Method Development and Validation; Design and Process Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, Process Characterization and Process Validation; Complaint and Product Failure Investigations, post market root cause analysis, CAPA, and Non-Conforming Material Reports; FDA 21 CFR part 820 and part 211ISO 13485, ISO 9001, and ISO 14971; DOE, ANOVA, Confidence and Tolerance Limits, Gage R&R, Capability analysis, and Six Sigma Methodology; Coating of medical devices for perfusion systems, Biocompatible coatings with and without Active Pharmaceutical ingredients (API), manufacturing of combination products; Control Environment Area (CEA) Validations, Control Environment Area Excursion Analysis and investigation.

Responsibilities

Developing and maintaining quality standards for processing materials
Collaborating with engineering and manufacturing teams
Implementing process improvements
Conducting quality assurance tests
Performing statistical analysis
Ensuring corrective measures meet reliability standards
Performing Risk Mgmt. Deliverables to include Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis
Supporting Design and Process Control deliverables to include Product Performance Specifications, Design Verification, Design Validation, approve product drawings/prints, Process Characterization and Process Validation
Providing support for Variable and Attribute Test Method Development and Validation
Providing support for Complaint and Product Failure Investigations, post market root cause analysis, Corrective and Preventive Actions (CAPA) and Non- Conforming Material Requests (NCMR)
Navigating government and quality regulations to include FDA 21 CFR part 820 and part 211 requirements and ISO 13485, ISO 9001 and ISO 14971
Utilizing statistical tools and software to include Design of Experiments (DOE), ANOVA, Confidence and Tolerance Limits, Gage R&R, Capability analysis and Six Sigma Methodology in auditing and ensuring quality outcomes
Providing specialized knowledge in the manufacturing process of Coating of medical devices for perfusion systems including Biocompatible coatings with and without Active Pharmaceutical ingredients (API), manufacturing of combination products
Coordinating Control Environment Area (CEA) Validations, Control Environment Area Excursion Analysis and investigation and utilize computer and software packages to include MS Office Suite, MS Project, MS Access, Minitab and SAP

Benefits

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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)