Senior Reliability Engineer
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. A Day in the Life In this exciting role as a Senior Reliability Engineer supporting released products within the Cardiac Ablation Solutions Operating Unit, you will provide technical leadership across all quality aspects of the commercial portfolio, including Health Risk Assessments, Post Market Surveillance, and Risk Management. This role will serve as a key partner to cross functional teams, guiding critical quality decisions that protect patients and ensure sustained product performance. Cardiac Ablation Solutions offers cardiac mapping and ablation solutions to treat patients with abnormal heart rhythms. It is focused on disrupting and leading the market with advanced ablation catheters, cardiac mapping systems, and conventional EP products. 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 onsite a minimum of 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
- Requires a Baccalaureate degree in Science, Technology, Engineering, Math or a related technical discipline with a minimum of 4 years of relevant experience OR Advanced degree with a minimum of 2 years relevant experience
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- Prior experience in the medical device industry across product development, operations, or quality functions
- Demonstrated expertise in risk management in accordance with ISO 14971
- Strong technical writing and communication skills, with the ability to clearly explain complex technical topics to non-technical audiences
- Proven ability to lead root cause investigations, solve complex technical problems, and perform statistical data analysis
- Knowledge of Microsoft Office Applications (Word, Excel, and PowerPoint) and Windows OS
- Familiarity with ISO 13485 Requirements
Responsibilities
- 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).
- Update Risk Management files (Risk Management Report, Hazard Analysis, DFMEA, etc.) including risk assessments for trending breaches, design and manufacturing issues, and projects.
- Create responses to Regulatory Inquiries, Issue Evaluations, Health Risk Assessments, and any general risk related questions.
- Author Periodic Safety Update Reports (PSURs).
- Analyze reliability data and identify trends and potential issues.
- Own CAPA investigations, corrective actions, and collaborate with cross functional team to resolve technical issues.
- Lead investigations into product failures, utilizing root cause analysis techniques to determine underlying causes; Support complaint trending and investigations of complaint trend excursions or quality signals from the field.
- Assess design and process changes for potential risk impacts.
- Generate, review, and approve FMEAs and design verification test reports in compliance with medical device design control requirements.
- Collaborate with design, manufacturing, and quality teams to implement design, process or supplier changes, corrective and preventive actions that enhance product reliability.
- Determine the need for further action or to document defendable rationales when no further actions are required.
- Demonstrate strong written and verbal communication skills.
- Provide technical mentorship and coaching to junior engineers.
- Work cooperatively as part of a global, cross-functional team
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
