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Sr Quality Engineer - Process Development and Manufacturing

Medtronic
Phoenix, AZ 85067
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Sr Quality Engineer - Process Development and Manufacturing

Location:

Tempe, Arizona, United States

Requisition #:

20000LHT

Post Date:

Dec 14, 2020


**Careers That Change Lives**

In this exciting role as a Senior Quality Engineer you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable electronic products at Medtronics Tempe Campus.


**CVG**


The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.


CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.


We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product when they need it. We have strong ties to our localcommunities.Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.


**Day in the Life**


Responsibilities may include the following and other duties may be assigned.


+ Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished product.

+ Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

+ Supports process development and manufacturing operations teams in equipment development, process developmet, IQ, OQ, PQ work and support activities such as FMEA, Test Method Validation and non-conformance containment and disposition.

+ Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

+ Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

+ Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.


**Must Have: Minimum Requirements**

Bachelors Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality


**Nice to Have (Preferred Qualifications)**


+ Engineering experience in a medical device manufacturing environment

+ Process Quality or Process Engineering experience.

+ Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)

+ Background inEquipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.

+ Strong statistical analysis techniques

+ Strong technical writing skills

+ Good overall communication and presentation skills, as well as experience with presentation tools and applications

+ Mechanical, Industrial or similar Engineering degree

+ Experience in integrated circuit and/or electronics assembly manufacturing

+ Six Sigma or Lean Sigma belt certification

+ DRM or DFSS certification

+ Experience with internal and external audits including FDA, MDSAP and/or TUV.


**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)


Travel up to 10%
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.

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Posted: 2020-12-24 Expires: 2021-02-22
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Sr Quality Engineer - Process Development and Manufacturing

Medtronic
Phoenix, AZ 85067

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