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1+ months

Principal Design Quality Engineer

Littleton, MA 01460
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Principal Design Quality Engineer


Littleton, Massachusetts, United States

Requisition #:


Post Date:

Sep 14, 2020

**Careers that Change Lives**

In this exciting role as a **Principal Design Quality Engineer** you will have responsibility for providing quality leadership to develop and
release an industry leading 3D X-ray Imaging System. This individual will be expected to apply
their knowledge of engineering, design control principles, reliability engineering
and quality techniques to positively influence design decisions. Will ensure products are developed and
manufactured in accordance with applicable industry standards, regulatory
requirements and to exceed customer expectations. Lead teams in gathering and evaluation of
technical data to solve complex product problems.

The **Restorative Therapies Group** develops
life-restoring therapies and healthcare solutions that span the care continuum;
integrating technologies and applying clinical and economic evidence to
increase patient access, improve efficiency of procedures and deliver
successful patient outcomes.

The **Cranial and Spinal Technologies** (CST) division of
RTG shapes surgery for the better; delivering cranial, spinal, and orthopedic
solutions. We are a leader in therapeutic biologics.We partner with
other healthcare stakeholders to accelerate ground-breaking innovations that
can improve surgicalefficiencies and help create better outcomes for more

**A Day in the Life**

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

+ Follow all Quality System Practices as definedby Medtronic Navigations practices, policies and Standard Operating Proceduresto ensure that FDA, ISO and European Medical Device quality standards andregulations are met where applicable

+ Lead design assurance activities in support ofdevelopment for electromechanical systems that utilize microcontrollertechnology, customized/off the shelf PCBs and software applications

+ Lead system and product continuous improvementprojects

+ Ensure the resolution of all issues raisedduring testing

+ Leads reliability predication and allocationmodeling, reliability plan writing and reporting

+ Lead problem solving techniques to problems ofmoderate to high scope and complexity

+ Lead complaint investigations; document findingsand provide reports and analysis

+ Develops, modifies, applies and maintainsquality standards and protocol for processing materials into partially finishedor finished materials product.

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

+ Devises and implements methods and proceduresfor inspecting, testing and evaluating the precision and accuracy of productsand production equipment.

+ Designs or specifies inspection and testingmechanisms and equipment; conducts quality assurance tests; and performsstatistical analysis to assess the cost of and determine the responsibility forproducts or materials that do not meet required standards and specifications.

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

+ May specialize in the areas of design, incomingmaterial, production control, product evaluation and reliability, inventorycontrol and/or research and development as they apply to product or processquality.

**Must Have: Minimum Requirements**

Bachelors Degree in Engineering, Science or technical field
with 7+ years of work experience in Engineering and/or Quality OR Masters
Degree Engineering, Science or technical field with 5+ years of work experience
in Engineering and/or Quality.

**Nice to Have**

+ Masters degree preferred

+ ASQ-CQE, CQA, CBA or equivalent certifications

+ Medical device experience; or experience in aregulated environment

+ Experience working with suppliers and/orcontract manufacturers

+ Strong analytical skills and statisticaltechniques

+ Excellent communication skills

+ Ability to work effectively within team andacross functions

+ Extensive background in product development

+ Familiar with reliability analysis and testmethods

+ Strong working knowledge of electromechanicalassemblies, special processes, design verification/validation techniques anddesign control

+ Familiar with the use of tools such as Six Sigmaand Kaizen

**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: 2020-09-17 Expires: 2021-01-24
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Littleton, MA 01460

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