Senior Quality Engineer – Trending and Data Analytics
About The Position
At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. In this exciting role as a Senior Quality Engineer supporting the Cardiac Ablation Solutions Post Market Quality organization, you will have responsibility for performing trending and analysis of customer feedback, complaint, and quality system data. The Cardiac Ablations Solutions Unit develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. This position is in Mounds View, MN within the Cardiac Ablation Solutions (C A S) Operating Unit and requires 4 days onsite per week. We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
Requirements
- Bachelor’s degree in engineering, math, statistics, or a technical discipline
- Minimum of 4 years of work experience in Engineering, Science, or Data Analysis OR Advanced degree in Engineering, Science, or technical discipline with 2+ years of work experience.
- Experience working with relational databases
- Experience using data analysis tools such as PowerBI, Spotfire, Tableau, or similar platform
Nice To Haves
- Strong analytical skills and experience with large, complex datasets
- Strong written and verbal communication skills and work cooperatively as part of a team and cross functionally
- Ability to manage project timelines to execute deliverables in a timely manner.
- Experience working or collaborating on regulatory submission documentation such as Clinical Evaluation Reports (CER) or Periodic Safety Update Report (PSUR)
- Ability to solve problems and innovate solutions.
- Medical Device Industry experience.
- Quality experience working in a regulated industry.
- Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
- Experience working with data analytics, visualization, and query tools such as PowerBI, Snowflake, SAP Business Objects, Tableau, Spotfire, Minitab, or JMP.
- Familiarity with these regulations: FDA 21 CFR Part 820, EU 217/745 (EU MDR).
- Familiarity with these standards: ISO 13485, ISO 14971, IEC 60601.
- Report validation and/or software validation experience
- Experience with and passion for Continuous Improvement
Responsibilities
- Performs trending for Cardiac Ablation Solutions products
- Escalates trending signals as appropriate
- Provides cross functional partners with data requests as needed
- Defines, tests, and validates new data sources and reports
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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
