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Prin Product Assurance Engineer
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Prin Product Assurance Engineer : Medtronic
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| Job Number |
MT_73338 |
| Employee Type |
Full Time |
| Company Name |
Medtronic |
| Location |
Tempe
Arizona
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| Salary (year) |
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| Experience |
6 to 9 Years |
| Industry |
Medical-Device |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
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| Description |
Division - Microelectronics
Business - Cardiac Rhythm Disease Mgmt
Position Description
Perform proactive Design for Six Sigma (DFSS)/ Design for Reliability and Manufacturability (DRM) engineering functions to ensure the quality and reliability of integrated circuits and hybrid assemblies that are used in implantable medical devices for the CRDM and Neuromodulation businesses.
Position Responsibilites
The candidate will be responsible for performing proactive DFSS/ DRM engineering functions to ensure the quality and reliability of integrated circuits/ hybrid assemblies that are used in implantable medical device and therapy delivery systems for the CRDM and Neuromodulation businesses.
The projects and assignments for which the candidate will support include the following:
1) Partner with New Product/ Technology Development to use Design for Six Sigma (DFSS)/ Design for Reliability and Manufacturability (DRM) methodologies to proactively develop robust, compliant new products aligned with requirements traceable to the Voice of the Customer, using predictive engineering and anticipating and managing potential issues.
2) Use a solid understanding of quality and reliability requirements to influence the selection of a compelling, superior concept that meets those requirements. Work with Design Assurance organizations within the CRDM and Neuromodulation businesses to resolve quality or reliability concerns with assigned products.
3) Flow down prioritized requirements (critical parameters) to the hybrid and components, both qualitatively (critical parameter flow down) and quantitatively (tolerance allocation), and aligning with suppliers and manufacturing. This would include the use of FMEA, FTA and other risk assessment tools to adequately address risk.
4) Use predictive engineering and optimization methods to ensure the components, hybrid and product are robust to processing and use conditions and are predicted to meet or exceed quality and reliability expectations. This would include working with product, component, design and process engineers to identify and perform the correct reliability stress tests and interpret the data for reliability predictions.
5) Establish verification and control methods so that the new product is capable of fulfilling functional and reliability requirements under normal and accelerated use conditions, and is manufacturable with high, predictable yield without rework and with high reliability.
6) Generate and ensure that documentation supporting product release is complete, compliant and meets requirements.
Basic Qualifications
EDUCATION::
- Bachelor of Science Materials, Mechanical, Electrical or Reliability Engineering degree and minimum of 6-10 years of experience in the area of quality, reliability and product development involving integrated circuits and related packaging or Master’s degree in same disciplines with strong reliability engineering focus and 4-10 years of experience.
SKILLS/EXPERIENCE/CERTIFICATIONS:
- Design for Six Sigma Black Belt desired; equivalent experience will be considered, if certification is lacking.
- CRE certification desired
- Strong track record of successfully managing quality and reliability tasks from start to finish, resulting in reliable and manufacturable sensor designs.
- Computer skills with Microsoft applications. Proven experience with RELEX and/or Cognition Cockpit software desired.
- Strong statistical analysis skills. Reliability data analysis and modeling skills with experience in Minitab, Weibull ++ or other reliability modeling software. Experience with Bayesian modeling desired.
- Good technical writing skills. Good overall communication skills. Good presentation skills and experience using presentation tools and applications.
- Must be team-oriented and able to lead quality sub-projects and initiate own assignments.
- Must be able to define general approaches and develop solutions to complex problems using imaginative, thorough, and practical solutions consistent with organization objectives.
- Must be capable of multiplexing tasks efficiently and effectively to schedule.
- Good interpersonal skills and ability to influence others.
- 8D, Corrective and Preventive Action planning and implementation skills preferred.
Desired/Preferred Qualifications
Physical Job Requirements
Physical Job Requirements
- Stand/ Sit/ Walk minimum of 8 hrs a day
- Microscope/ fine close work occasionally.
- Vision requirements correctable to 20/20 in 1 eye and 20/40 in other eye
- 100K Class Clean Room access required in 100K area – must comply with gowning procedures and ESD control.
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| Requirements |
Exempt/Non-Exempt - Exempt
Travel Percentage - less than 25%
Relocation - Relocation eligibility to be determined
Preferred Qualification
Physical Job Requirements
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