Distinguished Engineer

Distinguished Engineer

11 oct
|
Medtronic
|
Departamento de Santa Rosa

11 oct

Medtronic

Departamento de Santa Rosa

Guide development of significant, new fatigue test and structural analysis methods for innovative heart valve replacement and repair devices.  Using applied mechanics principles, lead the development of device- and material-level fatigue test methods to characterize structural reliability performance and demonstrate attainment of reliability requirements for evaluation of new device designs. 






Work in conjunction with product development teams to translate in vivo use conditions into appropriate boundary conditions for component structural analyses and device-level test methods.  Improve existing in-vitro testing processes, technologies and protocols to meet pre-clinical testing requirements.  Lead development of internal risk management procedures and external regulatory guidelines related to structural reliability. 


Lead the implementation of Design for Reliability and Manufacturability best-practices across multiple development projects.  Provides technical mentorship to engineers and technicians and serves as a technical leader in the group.


Responsibilities::

·        Interpret customer requirements and direct the definition of performance criteria, analytical approaches, and the selection of the optimum design methods.  Formalize testing and evaluation methodologies/approaches that result in comprehensive reliability testing and analyses of candidate designs.  Requires advanced, highly specialized technical insight and experiences.

·        Assume the leadership role in testing lab for development of test protocols and application of technologies to the structural evaluation of new product designs. Coordinate with engineers and technicians to train and develop testing capabilities.  

·        Develop, validate and implement new test techniques to fully address structural integrity of heart valve products.  Through in-vitro and in-vivo characterizations, identify and develop appropriate test and analysis methods that reasonably represent expected device physiologic loading conditions.  Prepare plans/reports and perform in-vitro testing of valve products and associated structural components. 

·        Formalize testing methodologies and approach to address comprehensive reliability analyses of designs

·        Help to define verification/validation testing and analyses that satisfy both regulatory and internal Medtronic requirements.

·        Acts as advisor to management and customers on structural reliability.  Requires broad perspective of market, company, and regulatory policies in addition to leadership capabilities.

·        Coordinate efforts of other technical personnel from internal or external sources to address areas of fatigue analysis, fracture mechanics, SEM imaging and failure modes analysis. Coordinate with outside consultants and clinicians to ensure testing and analyses required to fully qualify and verify device designs are appropriately representative of expected use conditions.

·        Prepare and deliver high quality presentation content on technical and procedural topics to management, marketing, clinicians, and other external stakeholders.


·        Prepare or direct the preparation of oral and written reports of current status, progress, and terminal status of projects, as required by the customer, project or department management.  Requires strong communications skills and ability to place large and complex topics in proper context.

·        Remain up-to-date with advancing technology related to implantable heart valve products and associated accessories.  Engage in continuing education programs to broaden knowledge in selected discipline and to gain knowledge in new fields of engineering, device testing, and project leadership.

·        Characterize the materials used in valve products by determining thermal/mechanical/chemical test methods appropriate to satisfy regulatory agency and Medtronic requirements.

·        Provide mentorship and training to engineers, technicians, or other specialists in areas of expertise.

Perform required training and certifications to demonstrate compliance with applicable divisional and corporate policies in accordance with training requirements.


EDUCATION REQUIRED:   

·        MS in Solid Mechanics, Materials Science or Mechanical Engineering

YEARS OF EXPERIENCE

·        Minimum : 10+

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