Sr. Quality Engineer

Position Description:

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.

Basic Qualifications: 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.

The position reports to Medtronic, Inc., 7611 Northland Drive, Brooklyn Park, MN 55428.

Salary: $109,000 to $145,200 per year.

THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com

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