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Sustaining Engineer II at Medtronic in Boulder, Colorado

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:


Careers That Change Lives
In this exciting role as a Sustaining Engineer you will have responsibility to work within the R&D Sustaining Engineering group, part of the Respiratory Interventions business group. The Sustaining Engineering group's primary responsibilities are to support Aircraft Medical products currently on the market and the Stewardship of McGRATH products following the transfer from development into commercialization.

As a Sustaining Engineer you will be responsible for the planning and execution of product design related changes and remediation by leading cross-functional teams and managing project execution from initiation through completion within the framework of Medtronic's Change Development Process (CDP). In addition to implementing design changes that enhance performance, address quality issues, and maintain compliance to applicable standards, the Sustaining Engineer performs root cause investigations, determines root cause, identifies and implements corrections and corrective actions, and serves as Corrective and Preventive Action (CAPA) owner as needed.

MITG
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

RESPIRATORY, GASTROINTESTINAL & INFORMATICS (RGI) offers a complete line of solutions that spans the continuum of care. We help with early detection and treatment of diseases, and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise.

A Day in the Life

  • Project planning and execution to ensure timely completion of tasks

  • Interface with all functional areas affected by projects including R&D, Manufacturing, Quality, Regulatory, Human Factors, Clinical, Packaging, Labeling, Suppliers and End Users as warranted.

  • Generate test protocols and reports and execute product testing within the Sustaining Lab at the Boulder, Colorado site.

  • Generate Engineering Change Orders to support product sustaining efforts.

  • Maintain Design History Files and Technical File Documentation.

  • Research, verify, and implement the replacement of end-of-life components while sustaining current product design intents.

  • Present project status to stakeholders, management and teams, as required.

  • Work to maintain product performance and quality of existing products by leading and assisting with issues relating to CAPAs, customer complaints and manufacturing processes.

  • Provide technical support for existing products by developing solutions for problems with a high level of accountability, moderate level of authority and minimal need for supervisory oversight.

  • Follow strict adherence to policies and procedures associated with an FDA controlled environment.

  • Provide direction and support to other Sustaining Engineers

    Must Haves: Minimum Requirements
    To be considered for this role, please ensure the minimum requirements are evident on your resume.


  • Bachelor's Degree with 2+ years of experience or Advanced Degree with 0+ years of experience

    Nice to Have


  • Bachelor's degree in Mechanical, Electrical, Bio-Medical, Software, Materials, Industrial Engineering or other scientific field

  • 3-4 years of experience or advanced degree with 2+ years of experience working in a sustaining and/or manufacturing engineering environment preferred

  • At least 3-4 years of experience with projects management preferred

  • Experience in Change Development Process (CDP) and/or analogous post commercialization change process

  • Experience and competence with Solid Works or other CAD Modeling program

  • PMP Certification

  • Demonstrated interpersonal skills in order to interact with, build and mature relationships with, and influence multi-disciplinary cross-functional resources

  • Experience with test method development, protocol generation, lab testing, and reporting

  • Application of statistical and analytical methods

  • Experience in development and sustaining of medical devices

  • Quality System experience in Medical Devices

    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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)


    Additional Information



    • Posting Date: Oct 27, 2020
    • Travel: No






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