Principal Reliability Engineer - CS

Medtronic Inc.•Mounds View, MN

24d•Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Careers That Change Lives 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. The Cardiac Surgery Operating 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, improving efficiency of procedures and deliver successful patient outcomes. In this exciting role as a Principal Reliability Engineer supporting the Cardiac Surgery Post Market Quality organization, you will have responsibility for supporting all aspects of Quality related to the commercial portfolio, including but not limited to Health Risk Assessments, Post Market Surveillance, and Risk Management. Areas of responsibilities include owning the risk management file and all associated activities, leading root cause investigations and CAPAs, performing Health Risk Assessments, supporting Field Corrective Actions (FCAs), performing Post-Market Surveillance. Collaborate with other Quality, RPE, Regulatory, and Manufacturing colleagues to ensure product issues, compliance concerns, supplier and manufacturing non-conformities are addressed and cost effective. Candidates must be able to understand design and risk implications to changes, collaborate cross-functionally, generate and review DFMEAs, test method validations and test reports in compliance with design control and risk management procedures used within the medical device industry. Candidates must also be willing to work in a fast-paced, multi-tasking, team environment. 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. This position is in Mounds View, MN. within the Cardiac Surgery (CS) operating unit. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

Requirements

Bachelor's in Science, Technology, Engineering, Math or a related technical discipline and a minimum of 7 years of technical experience OR a Master's degree with a minimum of 5 years technical experience

Nice To Haves

Expertise in risk management.
Strong technical writing skills; clear communication skills with the ability to clearly explain technical topics to non-technical audience.
Ability to manage multiple projects and timelines to execute deliverables in a timely manner.
Ability to solve problems and innovate solutions.
Quality experience working in a Medical Device Industry.
Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 10012, and ISO 17025.

Responsibilities

Risk Management: Support risk assessments and hazard analyses based on post-market data. Lead Health Risk Assessments to determine potential risk and recommend need for Field Corrective Action (FCA).
Post-Market Surveillance: Monitor product performance in the field, collect and analyze reliability data, and identify trends and potential issues.
Root Cause Investigation and Failure Analysis: Lead investigations into product failures and complaints, utilizing root cause analysis techniques to determine underlying causes. Support complaint trending and investigations of complaint trend excursions or quality signals from the field.
Reporting: Prepare and present reliability reports, metrics, and recommendations and regulatory authorities as required.
Continuous Improvement: Collaborate with design, manufacturing, and quality teams to implement design, process or supplier changes, corrective and preventive actions that enhance product reliability.
Regulatory Compliance: Ensure all activities comply with relevant standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971 EU MDR) and company policies.
Customer Interaction: Provide technical support to customers and field personnel regarding reliability issues and product performance.
Coaching: Provide technical mentorship and coaching to junior engineers.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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).
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).

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