Sr. Quality Engineer

Position Description:

Sr. Quality Engineer for Medtronic, Inc located in Fridley, MN. Responsible for the regulatory reporting of post market product performance to global external regulators. Develop and maintain cross-functional processes and practices to ensure on time performance execution and product market access. Prepare post market surveillance deliverables. Coordinate with technical and clinical experts across the operating unit to review all inputs to post market deliverables. Responsible for product knowledge related to Implantable Class II and Class III medical devices, implantable infusion systems, deep brain stimulation systems, neurostimulation systems for pain therapy, tibial nerve stimulation systems, and sacral nerve stimulation systems. Responsible for deficiency responses for EU MDR (Medical Device Reporting) and annual certificate surveillance work with notified body including TUV. Utilize R Programming Language (UmpSoft complaint monitoring software), Track Wise, PTC Integrity, Agile, SAP, Enovia and Documentum. Coordinate various Risk mgmt. activities following ISO 14971:2019 guidelines. Responsible for Post Market Surveillance Plans and Reports (PMS), Post Market Clinical Follow Ups (PMCFs), Periodic Safety Update Plan and Report (PSUR), Product Surveillance Reports (PSR) Plan and Reports supporting EU MDR Regulation 2017/745 and MDCG (Medical Device Coordination Group) 2022-2021 PSUR Guidance. Leverage Corrective and Preventive Actions (CAPA) and Field Corrective Actions (FCA) processes, and Quality System Regulation FDA 21 CFR Part 820 and ISO 13485. Work on Complaints Mgmt. and FDA Medical Device Report Adverse Event codes as well as Global Complaint Handling System. Responsible for post market surveillance inputs to regulatory Technical Documents. Responsible for post market surveillance inputs to support EU MDR certification and re-certification. Position works a hybrid model and will be onsite in Fridley, MN – 3 days per week. Relocation assistance is not provided for this position. #LI-DNI.

Basic Qualifications:

Master’s degree in Mechanical, Biomedical Engineering or closely related Engineering field with two (2) years of experience as a Quality or Reliability Engineer in the medical device industry. Or alternatively, Bachelor’s degree in Mechanical, Biomedical Engineering or closely related Engineering field with five (5) years of work experience as a Quality or Reliability Engineer in the medical device industry. Must possess at least two (2) years’ experience with each of the following: Class III devices, implantable infusion systems, deep brain stimulation systems, neurostimulation systems for pain therapies, tibial nerve stimulation, and sacral nerve stimulation systems; Deficiency responses for EU MDR and annual certificate surveillance work with notified body TUV; UmpSoft complaint monitoring software, Track Wise, PTC Integrity, Agile PLM, SAP, Enovia, and Documentum; ISO 14971:2019 and authoring of Risk Mgmt. Plans, Hazard Analysis and Risk Mgmt. Reports, and full life cycle updates; PMS, PMCFs, PSUR, PSR Plan and Reports supporting EU MDR Regulation 2017/745 and MDCG 2022-2021 PSUR Guidance; CAPA and FCA, QSR 21 CFR Part 820, and ISO13845; Complaints Mgmt., FDA Medical Device Report Adverse Event codes, and Global Complaint Handling System; Providing surveillance inputs for regulatory technical documents. Position works a hybrid model and will be onsite in Fridley, MN – 3 days per week. Relocation assistance is not provided for this position.

Salary: $128,100 to $141,600 per year

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