Senior Reliability Engineer - Neuromod - Rice Creek, MN

$101,600 - $152,400/Yr

Medtronic - Fridley, MN

Full-time - Mid Level

Hybrid - Fridley, MN

Professional, Scientific, and Technical Services

About the position

In this exciting role as a Senior Reliability Engineer you will have responsibility for many aspects of product quality and reliability for products that are released as part of Medtronic Neuromodulation organization. In this role, you will investigate issues and analyze the risks for products in the field. This includes trends in complaint data, labeling, software, and hardware related issues. You will also provide risk and reliability engineering support for released product design and process changes. The Reliability Engineer II ensures that all analysis meets acceptable reliability standards, and that documentation is compliant with requirements.

Responsibilities

• Lead investigations into fielded product issues including performing the risk analysis for the issue with a comparison to the risk management files and impacts to existing risk mitigations.
• Determine and initiate change request if risk management files need to be reviewed and updated.
• Collaborate with Medical Safety to review and analyze field data, discuss the harm severity sources, and estimate the probability or harm occurrence.
• Participate in the identification, assessment, and disposition of software anomalies.
• Evaluate reliability impact of proposed design and manufacturing changes on existing market released product. This includes physical hardware changes as well as, embedded firmware, and health software applications.
• Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with a product nonconformance, complaint, design, or manufacturing change.
• Represent the organization as a technical contact for risk and reliability for processes such as: Non conformances, Anomaly Dispositions, Deviations, Complaint Formal Investigations, Change Control and CAPA among others.

Requirements

• Bachelor's degree required with a minimum of 4 years of experience in Medical Device or related industry.
• OR advance degree with a minimum of 2 years of experience in Medical Device or related industry experience.

Nice-to-haves

• Experience in Medical devices - specifically in Neuromodulation devices is preferred.
• Experience with Software Application or Embedded Software development and testing.
• Experience in medical devices or other highly regulated industry such as defense or automotive.
• Experience in quality, reliability, design assurance, safety, or systems engineering.
• Experience with and knowledge of medical device standards including ISO 13485, ISO 14971 (risk mgmt.).
• Formal training in quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
• Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships.
• Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude.
• Ability to lead cross-functional teams and drive discussion and decision-making. This includes facilitation, consensus building and conflict resolution.
• Strong written and oral communication skills including presentation skills.
• High degree of initiative and self-motivation.
• Strong attention to detail and accuracy.
• Excellent organization skills: ability to successfully balance and prioritize multiple ongoing projects/tasks.
• Strong analytical skills and the ability to solve problems through analytical reasoning.
• ASQ Certification in Quality or Reliability is a plus.
• Experience in the design, maintenance, or continuation engineering of software or software systems, including mobile applications is a plus.

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)