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Within the R&D group developing and sustaining interventional gastrointestinal catheters and associated products, the R&D Engineer will apply their engineering knowledge and experience, along with expanded knowledge of medical device fundamentals, to support the design and development of new products and sustaining engineering of marketed products.  An R&D Engineer uses both experience and technical proficiency relative to their engineering field to perform tasks on a variety of projects.  


ESSENTIAL DUTIES AND RESPONSIBILITIES:

1.       Research and Development activities will include supporting appropriate scale development projects from concept through production transfer. 

2.       Sustaining activities will include supporting complaint investigations, determining root cause failure modes, and implementing design and/or process solutions that either enhance performance or address quality issues, and coordination of ongoing shelf life qualifications. 

3.       The engineer is responsible for implementing test requirements, facilitating or performing testing to support implementation of the changes to the product, including documentation of investigations and change implementation. 

 

 

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

1.       Develop design concepts, components, and assemblies of prototypes, and generating engineering specifications, including creation of design and assembly prototypes for feedback and testing.  Turns concepts into fully functional products.

  • Develop and perform engineering tests, measurements and analysis.
  • Perform engineering testing on animal and human tissues.
  • Troubleshoot technical problems, determine and execute resolution plans.
  • Develop manufacturing, technical and organizational processes.
  • Participate in the selection, development and qualification of component suppliers.

2.       Document critical information within presentations, memos, protocols, reports, reviews and notebooks.

3.       Collaborate with a multi-disciplinary project team and other functional areas to achieve project targets.

4.       Execute assigned tasks within the project scope, budget and timeline.

5.       Instruct technical support staff regarding testing and build requirements, and may train and/or provide work direction to technicians or assembers.

6.       Participate in design reviews.

7.       Comply with all company policies and procedures.

8.       Maintain a clean, safe, and orderly work area.

9.       Presents project status to management and teams, as required.

10.    Works independently to plan and schedule own activities necessary to meet timelines, and develops and tracks work schedule and assignments.

11.    Contributes to intellectual property position of company by inventing concepts and designs for new products/processes and submitting idea disclosures.

12.    Performs troubleshooting on new products/process problems as related to design, material, or process.

13.    Designs and coordinates standard engineering tests and experiments.

14.    Designs, procures, and fabricates tooling and fixtures.

15.    Completes verification and validation testing, including animal studies as needed.

16.    Prepares accurate and thorough test reports/documentation to communicate results to technical community and support regulatory submissions.

17.    Maintains a comprehensive and accurate laboratory notebook, document concepts, designs, drawings, and processes.

18.    Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.

19.    Demonstrates medical device design controls knowledge through delivery of high quality deliverables.

20.    Provides engineering and technical support of products in the field, which will include travel to cases.

21.    Follows strict adherence to policies and procedures associated with an FDA controlled environment.

22.    Generates Engineering Change Orders to support product sustaining and product development efforts.

23.    Works with clinician’s technical issues and communicates solutions at the appropriate level.

24.    Identifies immediate solutions for short term corrections to prevent impact to business goals.

Required:

  •            Bachelor’s degree in Mechanical, Biomedical or related technical  field.
  •      2-6 years of experience in medical device industry with a track record of success in mechanical engineering and product life cycle support

·         (with Master’s degree):  0-3 years of experience in medical device industry with a track record of success in mechanical engineering and product life cycle support.

  • Intuitive and insightful problem-solving capability with a proven record of aptitude and strong performance relative to a specific engineering field.
  • Intermediate skill using industry standard computer aided design software.
  • Intermediate skill using industry standard business and productivity software.
  • Some experience designing, developing, and qualifying components as part of a product or system.
  • Some experience with prototyping tools, materials and technologies.
  • Some experience using electrical and mechanical measurement equipment.

 

Preferred:

·         Some experience in the development of consumer level or medical products.

·         Basic knowledge of human anatomy and physiology.

·         Basic knowledge of surgical procedures and techniques.

  • Some experience determining engineering specifications and test requirements.
  • Some experience in various manufacturing assembly methods.
  • Some experience working with cross-functional teams to execute project plans.
  • Experienced using standard engineering documentation practices.

WORKING ENVIRONMENT/PHYSICAL ACTIVITIES:

 

Usual office environment with frequent* sitting, walking, standing, kneeling, crouching, crawling, balancing, stooping and occasional* climbing.

 

Frequent* use of eye, hand and finger coordination enabling use of office machinery.

 

Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone. 

 

Light physical effort required by handling objects up to 20 pounds occasionally* and/or up to 10 pounds frequently.

 

*Occasional: Activity exists less than 1/3 of the time.

*Frequent:    Activity exists between 1/3 and 2/3 of the time.

 

Engineering labs and clinical (hospital or clinic) environment

 

International travel to Design Centers, Manufacturing plants and Contract manufacturing facilities


DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 

Medtronic is an equal opportunity employer, M/F/D/V.


No relocation assistance available. Must be willing/able to relocate at own expense if not local to Sunnyvale, CA.

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