24 days old

Sr Design Quality Engineer

Medtronic
North Haven, CT 06473
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  • Job Code
    200004QA

Careers that Change Lives

MITG

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

The Sr Design Quality Engineering position on the team supports new product development for the Powered Stapling Platform. In this role, the Sr Design Quality Engineer works as part of the quality team supporting the cross functional design and process focus activities. An understanding of electro-mechanical design, process development, process validation, lean manufacturing, and/or design for reliability/six sigma is preferred. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.

POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:

  • Represent the quality engineering function as part of a cross functional team in new product and process development,
  • Assesses overall product risk by facilitating the development of risk management tools such as the risk management report, failure mode and effects analyses (FMEAs), etc.
  • Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required.
  • Contributes to the successful completion of Process Validation initiatives by facilitating validation master plans and the qualification activities required to meet validation requirements.
  • Perform Gage R&R and correlation studies.
  • Contributes to reviewing project documentation, participating in product risk assessments, and working with Product Development to establish appropriate verification and validation testing requirements.
  • Monitors supplier performance and initiates corrective actions, as required. Develops part qualification plans and supports the production part approval process.
  • Collaborates with cross-functional project team members as well as members of the QA extended team.
  • Tracks timelines and facilitating the required Quality Engineering deliverables.
  • Assisting with projects and assuring proper and consistent implementation of the quality engineering tools.
  • Provide support to other quality groups to assure efficient completion of project requirements.
  • Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
  • Provide guidance on the principles of applicable standards as they relate to the new product development activities of electro-mechanical medical devices


Embedded Responsibilities:

  • Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.
  • Statistical knowledge and Minitab experience. Demonstrated ability to document test data, analyze test results utilizing statistics, write clear and concise lab reports, and make recommendations to evaluate product.

MUST HAVE: MINIMUM REQUIREMENTS:

EDUCATION REQUIRED:

  • B.S. degree in Engineering, Math, Physical Science, or equivalent field
  • Preferred: M.S. degree in Engineering, Math, Physical Science, or equivalent field

YEARS OF EXPERIENCE:

SENIOR LEVEL:

  • Minimum Experience: 5+ years of experience in a regulated industry (2 years of experience can be substituted for an Advanced degree in a related discipline)

SPECIALIZED SKILLS OR EXPERIENCE:

  • Fundamental understanding of mechanical/electrical designs and manufacturing processes to support designing, troubleshooting, refining and qualifying the new product to ensure the sustainable manufacturing of medical devices both internal and external.
  • Fundamental understanding of production controls and production control development (Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses).
  • Experience in a regulated industry
  • Experience with Minitab or similar statistical analysis tools
  • Good interpersonal skills; Ability to work effectively in a team environment and build strong working relationships.
  • Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude

  • Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).
  • High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning.

NICE TO HAVE:
  • ASQ Certified Quality Engineering (CQE)
  • Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
  • Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints
  • Support reliability activities for new product development. Drive for root cause understanding and corrective action implementation to ensure product meets reliability requirements.

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 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)





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Posted: 2020-03-14 Expires: 2020-04-12

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Sr Design Quality Engineer

Medtronic
North Haven, CT 06473

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