Medtronic · 1 day ago
Sr. Quality Engineer
Brooklyn Park, Minnesota, United States of America
Full-time
Onsite
Mid, Senior Level
$109K/yr - $145K/yr
4+ years expMedtronic is a leading medical technology company, and they are seeking a Sr. Quality Engineer to develop and maintain quality standards for processing materials. The role involves collaborating with engineering and manufacturing teams, conducting quality assurance tests, and ensuring compliance with quality regulations.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Responsible for developing and maintaining quality standards for processing materials, collaborating with engineering and manufacturing teams, and implementing process improvements
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
Qualification
Required
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 211, ISO 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
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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
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