Sr Reliability Engineer

Careers that Change Lives

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That's the Medtronic Mindset - our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

We are looking for a dynamic and adaptive Sr. Reliability Engineer, with the desire to be part of the fast-growing Surgical Innovations business, helping us to ensure they exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.

This position provides reliability engineering support on new development projects. The candidate will be a key player in cross-functional teams and serve as a compliance and technical representative for reliability, safety, and quality functions.

As part of Quality project teams, the Sr. Reliability Engineer will define, contribute, and execute the quality plan for ensuring compliance to regulatory requirements. This position will collaborate with multidisciplinary teams and provide guidance to technical issues, guidance to external supplier remediation, engagement in design and risk reviews, and contribute to development activities.

Surgical Innovations:

Surgical Innovations provides. These clinical and economical solutions will enable clinicians to treat patients with safer, faster, and easier, and with more predictable procedure times and outcomes.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

The Senior Reliability Engineer position on the team supports new product development for various product families in the Surgical Innovations Business. In this role, the Senior Reliability Engineer works as part of the quality team supporting the cross-functional core team. An understanding of Reliability Engineering combined with Defect/Issue Management, Reliability Test Method Development/Setup/Analysis, Reliability Demonstration Analysis, Develop/Conduct Reliability studies and evaluations, Mechanical and Electro-Mechanical Design, Design Verification, Design Validation, process validation, Reliability (Planning, Allocation, Modeling, Prediction, Strategy, Assessment), Reliability Test Development, Electromagnetic Compatibility (EMC) Requirements/Testing/Development, Risk Management process per ISO 14971 at Reliability Engineering level is preferred. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.

Must Have: Minimum Requirements

• Bachelors degree required

• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

• Bachelor's Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality

• Experience working in large organization with cross-functional peers.

• Proficiency with Microsoft Office applications, Word, PowerPoint, Teams, OneDrive

• Proficient and Effective use of Microsoft Excel and knowledge of advanced formulas to manipulate data.

• Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO9001, 13485, and 14971 requirements.

• Knowledge of Reliability Testing and development, analytical tools, and methods, including Statistical Quality Control/Statistical Process Control (Minitab preferred), Design Of Experiments (DOE) and the use of computer/software packages related to reliability, design, development, and manufacturing.

• ASQ Certified Reliability Engineering (CRE) and/or Quality Engineering (CQE), or Certified Quality Auditor (CQA)

• Six Sigma Green belt or Black Belt certified

• Experience in a regulated environment (FDA, ISO, etc.)

• Experience working in a regulated industry with knowledge of common applicable standards for ablation systems like 60601-1 (electrical safety), 14971 (risk mgmt.) and 10555 (intravascular catheters).

• Strong understanding and experience in the application of statistics.

• Develops, coordinates, and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.

• Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.

• Solid understanding of electrical systems

• Understanding of the product development process including methods for determining design inputs, evaluating multiple designs, and designing, executing the appropriate verification and validation tests, completing risk management deliverables, gaining internal and regulatory approval, and launching new products.

• DRM expertise with working knowledge in multiple DRM practices and demonstrated ability to use DRM tools.

• Compiles and analyzes performance reports and process control statistics.

• Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer, and governmental agency reliability objectives.

• May develop mathematical models to identify units, batches or processes posing excessive failure risks.

• Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.

• Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude.

• Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).

• High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning.

• Good interpersonal skills: Ability to work effectively in a team environment and build strong working relationships. Effective communication skills, both written and oral and must be computer literate.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)