Reliability Engineer I -CS

Medtronic • Mounds View, MN

17h • $69,600 - $104,400 • 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. 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 Reliability Engineer I supporting the Cardiac Surgery Post Market Quality organization, you will have responsibility for supporting Post Market Surveillance, Risk Management, Shelf Life testing and complaint investigations associated with all Cardiac Surgery products. Areas of responsibilities will include writing Issue Impact Assessments (IIAs), excursion memos, and Periodic Safety Update Reports (PSURs); and supporting Field Corrective Actions (FCAs), Product Hold Orders (PHOs), CAPAs, Complain Investigations, and Shelf-Life testing. 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. 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. 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 required in science, technology, engineering, math or technical discipline is required

Nice To Haves

• Strong written and verbal communication skills and work cooperatively as part of a team and cross functionally.
• 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

• Completes risk assessments to investigate and confirm the impact of quality issues for potentially affected product in the field.
• Reviews and trends coding of events to capture findings.
• Collaborates with cross-functional teams to support timeliness metrics and complete in-depth investigations from field signals.
• Responsible for supporting complaint investigations.
• Responsible for executing test method validation.
• Perform post-market Risk Mgmt. Deliverables to include Issue Impact Assessments (IIAs), Complaint Trending, Periodic Safety Update Reports (PSURs) and Shelf-Life testing.
• Provide support for continuous improvement projects and changes, Field Corrective Actions (FCAs) and Product Hold Orders (PHOs).

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees