1+ months

Senior Product Engineer

Tempe, AZ 85282
Senior Product Engineer


Tempe, Arizona, United States

Requisition #:


Post Date:

Sep 28, 2020

**Careers that Change Lives**

TheSenior Product Engineerwill be an integral member of the Released Product Engineering team within MTC Hybrid Operations with primary Product ownership for yield management/improvement and product change management for our Neuro hybrid products. The Senior Product Engineer will partner with the Hybrid Manufacturing, Component and Quality Organizations as a pro-active problem solver to help identify, document, resolve or escalate major risks and issues while ensuring compliance with Regulatory requirements.

The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business and products.

A Day in the Life

+ Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of hybrid components; analysis of customer returns; supplier related engineering changes and optimizing hybrid production relative to cost constraints.

+ Leverage Medical Device Manufacturing experience to establish, communicate, implement and execute on Remediation initiatives to ensure the Mfg. meets the Regulation and Medtronic requirements for Compliance and Patient safety.

+ Define component and finished product qualification strategy, partner with Sourcing and MFG Engineering to develop qualification plan, report performance, and demonstrate release readiness. Define control plans to ensure appropriate acceptance activities.

+ Drive supplier requirements and supplier performance objectives by collaborating effectively with Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs.

+ Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness. Resolve product, test system and mfg failures and focus actions on the root cause.

+ Assure compliance to procedures and timely completion of CAPAs and audit findings.

+ Understand and leverage development protocols including Installation Qualification (IQ), Operational Qualification (OQ), a Performance Qualification (PQ), Special Process Validations, and Test Method Validations (TMV).

+ Provide RD support for manufacturing transfers, where applicable.

+ Produce engineering reports to provide technical explanation to support domestic and international regulatory submissions.

+ Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.

+ Optimize and refine existing products to improve performance.

+ Identify problems and recommend solutions.

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

**Nice to Have**

+ Class II and III medical devices and regulations to include ISO13485, ISO9001 and FDA CFR.

+ Understanding of Manufacturing Process: advantages/disadvantage of various manufacturing methods for different commodity types, manufacturability, assembly, relation to design specifications, up and down requirements flow, traceability, and process control.

+ Knowledge of micro-electronic packaging manufacturing technologies and equipment and processes including Die Attach, Wirebond, Transfer Mold, Direct Chip Attach, solder paste and reflow processes, PWB final sizing technologies including mechanical Rout/De-panel, Wet Saw Singulation and Excise, and dimensional verification using optical metrologies for packaging assembly

+ Knowledge of micro-electronic package test application development and test systems.

+ Experience with use of statistical process control and data analysis tools.

+ Experience with Lean Sigma/DFSS/DRM/DMAIC methodology

**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. Lets 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)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2020-10-01 Expires: 2020-12-06

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Senior Product Engineer

Tempe, AZ 85282

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