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Principal Released Product Quality Engineer

Littleton, MA 01460
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Principal Released Product Quality Engineer


Littleton, Massachusetts, United States

Requisition #:


Post Date:

Sep 10, 2020

**Careers That ChangeLives**

In this exciting role as a **Principal Released ProductQuality Engin** **eer** you will have responsibility for providing quality leadership
to released product engineering of an industry leading 3D X-ray Imaging System. This individual will be expected to apply their
knowledge of engineering, design control principles and quality techniques to positively
influence design changes and ongoing manufacturing. 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.

**Neuromodulation** delivers innovative therapies
and solutions for neurological diseases, pain, and spasticity

**A Day in the Life:**

+ Assists in setting priorities and strategyfor release product engineering projects to support customers, manufacturingand distribution of commercially released products.

+ Leads or participates as Quality Engineeringrepresentative on cross-functional teams including mechanical, electrical,software, systems, and test engineering to drive improvement in product qualityand reliability.

+ Providesguidance to Quality Engineering staff and other personnel and ensures thatdesign control requirements are being met in an effective manner.

+ Writes, evaluates and approves design andprocess test protocols and reports to ensure that the testing is sufficient tomeet regulatory requirements and quality objectives

+ Identifies and manages risk throughout thedevelopment process with the use of FMEA and/or other risk managementtools. This includes leading the Riskmanagement efforts of the design process and working with design team andmanagement team on managing product and process risks.

+ Coordinates with supplier quality toestablish and execute quality requirements for contract manufacturing, internaland external suppliers.

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

+ Collaborates with engineering andmanufacturing functions 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.

+ Lead or participate in design reviews toevaluate designs and to help identify alternative design solutions.

+ Ensures that corrective measures meetacceptable reliability standards and that documentation is compliant withrequirements.

+ RepresentMedtronic as appropriate in FDA, notified body, internal, and other audits.

+ Mayspecialize in the areas of design, incoming material, production control,product evaluation and reliability, inventory control and/or research anddevelopment as they apply to product or process quality.

**Must Have: MinimumRequirements**

**Tobe considered for this role, please ensure the minimum requirements are evidenton your resume.**

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

**Nice to Have:**

+ Experience with capital equipmentincluding mechanical hardware, electrical hardware, software, and systemsintegration.

+ Experience with medical device lasersand radiation emitting equipment.

+ Extensive knowledge of quality tools:

+ Riskanalysis

+ Highlyproficient in math and use of statistical techniques

+ Sixsigma

+ Designof experiments

+ Leanprinciples

+ Rootcause analysis

+ Problemsolving approaches

+ Reading and correcting drawings

+ Use of various tools, includingmicroscopes, calipers, and other inspection equipment.

+ Computer literate; use of wordprocessing, spreadsheets

+ Project management methods and tools

+ Quality System Regulation (QSR)

+ Medical Device Directives (MDD) andEuropean Union Medical Device Regulation (EUMDR)

+ ISO standards for medical devices andcapital electrical equipment

+ FDA requirements and guidance

+ Good Manufacturing Practices (GMP)

+ Good Laboratory Practices (GLP)

+ Recognize problems and proactively take correctivemeasures

+ Self-motivated and committed to a team approach

+ Strong interpersonal, organizational and projectmanagement skills

+ Strong oral, presentation and technical writing skills

+ ASQ certification in Quality Engineering related areas

+ Demonstrated skills in decision making preferablyacross a broad spectrum of Quality Engineering responsibilities.

**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: 2020-09-15 Expires: 2020-10-23
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Littleton, MA 01460

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