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1+ months

Sr Design Quality Engineer

Medtronic
North Haven, CT 06473
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Sr Design Quality Engineer

Location:

North Haven, Connecticut, United States

Requisition #:

20000ITR

Post Date:

Feb 11, 2021


**Careers That Change Lives**


In this exciting role as a Senior Design Quality
Engineer you will have responsibility for contributing to the design and
development of Instrumentation that will be utilized to deliver targeted
therapy in conjunction with Medtronics surgical robotic system. This role will be responsible for guiding and
helping developing Design Quality Engineers across the organization.


**MITG**


The Surgical Robotics business
strives to enable earlier diagnosis, better treatment, faster complication-free
recovery, and enhanced patient outcomes through less invasive surgical robotic solutions.


**SURGICAL ROBOTICS** sets
the standard for Minimally Invasive Surgery (MIS) by creating innovative
surgical products and services that focus on obesity and diseases and
conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region,
and the head and neck.


**A Day in the Life**


**Responsibilities may include the followingand other duties may be assigned.**


+ Supportthe design quality for a capital hardware subsystem for the Minimally InvasiveSurgical System, including documentation and other supporting quality evidence.

+ Facilitateand manage Design and Process FMEAs/FMECAs in a research and developmentsetting for the Wristed and Advanced Instrumentation and potentially othersubsystems within the Minimally Invasive Surgical System.

+ Provideguidance and oversight of the plans and methods for subsystemverification.

+ Providedirection on correct GDT leading to identification of Critical to Qualityelements.

+ Provideoversight and approval for Reliability Plans, Protocols and Fixtures and ensurethat they are properly executed throughout the development and qualificationprocesses.

+ Participatein engineering Design Reviews.

+ Participatein Defect / Issue Management and Change Control Boards, as appropriate.

+ Collaborateand Manage the Risk Management Process per ISO 14971

+ Qualifyproduction components through Surgical Robotics Production Part ApprovalProcess (PPAP)

+ DevelopQuality inspection procedures, including sampling plans, for both productionlevel components and finished devices.

+ Initiatecorrective action requests on non-conformances (internal or external) andverifying the effectiveness of corrective actions.

+ Contributeto the development of Process Flows, Control Plans, Design of Experiments,Measurement Systems Analyses, and Process Capability Analyses.

+ Ensureall FDA and ISO validation requirements are met and for the review and approvalof all validation protocols (IQ, OQ, PQ and MSA).

+ Ensureinternal Design Control policies and procedures comply with regulations andexternal standards, including software regulations, risk management, and changecontrol.

+ Contributeto the streamlining and continuous improvement of the product developmentprocess to ensure robust and efficient development and launch of new andinnovative products.

+ Provideguidance for the application of internal development procedures, includingDesign Control, to the product development teams, within the framework ofregulatory requirements.

+ Interactand form constructive working relationships with all levels of leadershipwithin Quality, Procurement, Marketing, RD, and Operations


**Must Have: MinimumRequirements**


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


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


**Nice to Have**


+ MastersDegree in Engineering.

+ Experiencewith New Product Development in the medical device industry.

+ Greenor Black Belt Six Sigma Certification (DFSS or DMAIC)


**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 JobRequirements**


The above statements are intended to describe the general
nature and level of work being performed by employees assigned to this
position, but they are not an exhaustive list of all the required
responsibilities and skills of this position.


The physical demands described within the Day in the Life
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.


Travel = 10% to domestic and/or international supply
chain
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: 2020-11-13 Expires: 2021-03-26
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Sr Design Quality Engineer

Medtronic
North Haven, CT 06473

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