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Principal Reliability Engineer

📁
Engineering
📅
19000FPG Requisition #

Careers That Change Lives

 

In this exciting role as a Principal Reliability Engineer, you will have responsibility for performing post market risk assessment to support product issues or changes associated with product design or manufacturing process; supporting product performance monitoring; and providing continuation quality support for Targeted Drug Delivery (TDD) products (Infusion pumps, catheters and kits).

 

Neuromodulation Pain Therapies

 

The Pain Therapies division offers solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer, and severe spasticity. Targeted Drug Delivery for chronic pain and severe spasticity is part of the Pain Therapies division of Restorative Therapies Group (RTG).

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

 

 

A Day in the Life

·       Identify hazards inherent to design, sequence of events, hazardous situations, impact to patient safety and probability of harms associated with post market product nonconformances. Complete risk analysis and present the results at review meetings for issue impact assessment in support of fielded product containment decisions.

·       Evaluate the impact of proposed design or manufacturing changes on market-released products and complete risk assessment as part of the post market change evaluation process.

·       Complete risk analysis in regulatory assessment of change for regulatory submission of design or manufacturing changes.

·       Support manufacturing changes by reviewing and approving component, finished device, labeling or manufacturing qualification plans and reports.

·       Collaborate with cross-functional teams in field complaint data review, conduct risk management file review, lead risk analysis and author Health Hazard Assessment (HHA) in support of CAPA or field action for TDD products.

·       Lead post market field performance analysis of TDD products. Utilize statistical analysis software to complete data analysis and provide data-driven recommendations. Present data analysis summary and recommendations at project team or management review meetings.

·       Assist project owners in developing search criteria for field complaint data queries.

·       Provide leadership in risk analysis and solutions for complex post market product issues. Work independently to determine and develop solutions that are thorough, practicable and compliant to regulations.

·       Follow all Quality System practices as defined by Medtronic RTG and Neuromodulation practices, policies and Standard Operating Procedures to ensure compliance to FDA, ISO and European Medical Device quality standards and regulations.

·       Participate in technical design reviews, project/CAPA phase reviews and change control reviews.

·       Effectively and independently manage deliverables to meet project timelines and department metrics.

·       Provide technical guidance and coaching to peers in the post market Quality organization.


 

Additional responsibilities may include the following:

  • 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.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • 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.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.


Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Master’s Degree Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality in highly regulated industry.

 


Nice to Have

·       Fundamental knowledge of FDA, ISO 13485 and ISO 14971 requirements for medical device industry

·       Strong communication skills, both oral and written

·       Ability to work independently with minimal supervision

·       Strong leadership and good people management skills to lead cross-functional teams in support of business needs and resolving product-related or quality-related issues

·       Experienced in Excel, Minitab and PowerPoint

·       Experience in medical device industry or other highly regulated industry

·       Working experience in Design, Quality or Operations

·       Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, analysis tools and methodologies to understand and quantify risks

 

 


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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

 

The physical demands described within the Day in the Life 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.

 

Travel: less than 10%

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Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
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