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Sr Quality Engineer - New Product Development

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Engineering
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18000E2Q Requisition #
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Careers that Change Lives

You will be a key member of the Medtronic Quality Engineering team working to commercialize a Surgical Robotics Platform.  You will join the product development team as the quality representative on a cross-functional team responsible for product development/change including:  design verification (Design for Six Sigma), reliability engineering, component specification / approval, process evaluation and nonconforming product analysis in a product team environment.  

Impact patient outcomes.  Come for a job, stay for a career.

The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. SURGICAL INNOVATIONS 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

You will ensure that component and finished devices are properly specified and inspected, and the associated manufacturing processes are properly designed, analyzed and validated.  

You will:
Lead overall responsibility for ensuring the adequacy of design quality system engineering test activities for a Minimally Invasive Surgical System, including documentation and other supporting quality evidence.  
Facilitate and manage the planning, development, and approval of Design Verification and Regressing testing.  
Provide guidance and oversight of the plans and methods for verification and regressing testing. 
Provide guidance on the principles of electrical engineering and IEC standards as they relate to the new product development activities of electromechanical medical devices. 
Provide oversight and approval for Reliability Plans pertaining to capital equipment and ensure that they are properly executed throughout the development and qualification processes.
Participate in the development of Test Methods, Test Method Validations and subsequent approval Engineering Report.
Utilize knowledge in statistical analyses to collaborate with Test Engineering team on the optimal approach for analyzing test data and determining Pass/Fail criteria.
Ensure all fixtures, gages and tools used for the purposes of Design Verification have been properly validated per internal Design Control procedures.
Participate in Defect / Issue Management and Change Control Boards, as appropriate.
Support in the construction and maintenance of the Risk Management File per ISO 14971 at a System Engineering level. 
Initiate corrective action requests on non-conformance (internal or external) and verifying the effectiveness of corrective actions. 
Contribute to the development of Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses.
Ensure all FDA and ISO validation requirements are met and for the review and approval of all validation protocols (IQ, OQ, PQ and MSA).
Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative products.
Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements.
Interact and form constructive working relationships with all levels of leadership within Quality, Test Engineering Procurement, Marketing, R&D, and Operations.
Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.

Must Have: Minimum Requirements

You must hold a minimum of a Bachelor’s degree in Mechanical or Bio-Medical Engineering, Math, Physical Science, or other related field with 4+ years of experience of developing complex electro-mechanical and/or robotic systems in a regulated industry.


Nice to Have
  • Experience in design, manufacturing or quality engineering position (medical device experience preferred). 3 years of experience can be substituted for an Advanced degree in a related discipline.  
  • Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer software packages related to design, development and manufacturing.  
  • Statistical Quality Control/Statistical Process Control, Design of Experiments, Failure Mode and Effects Analysis.  
  • Experience in a regulated environment (FDA, ISO, etc.)
  • Good communication skills, both written and oral and must be computer literate.
  • Knowledge of or experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO 14971, ISO 13485 requirements.
  • In-depth knowledge and experience in the use analytical tools and methods, including statistics (Minitab preferred), DOE and the use of computer/software packages related to design and development.
  • ASQ Certified Quality Engineering (CQE), Certified Quality Auditor (CQA)
  • Six Sigma Green belt or Black Belt certified
  • Geometric Dimension and Tolerance (GD&T) 
  • Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO9001, 13485, and 14971 requirements.

WORKING CONDITIONS:
Standard office setting, surgical lab, operating room, pilot lab, external research organizations, supplier visits
Distributed R&D teams
Some travel may be required, mostly to Boston, MA  
  

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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements
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.

EEO
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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees 

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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