26 days old

Design Quality Engineering Manager

Medtronic
North Haven, CT 06473
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  • Job Code
    200004Q8

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 Quality Engineering Manager position on the team supports new product development for the Powered Stapling Platform. In this role, the Quality Engineering Manager works as part of the quality team supporting the cross functional core team while managing and developing a quality engineering team through the quality supplier, design and process focused activities. An understanding of electro-mechanical design, process development, process validation, part qualification, 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:

  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Supports audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Co-ordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, R&D, and Operations.
  • Utilize coaching and facilitating skills with program shareholders and software quality team members to ensure proper project management, expectation setting, and best practices are utilized.
  • 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.

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 relevant experience in a regulated industry, or advanced degree with a minimum of 3 years prior relevant experience.

    SPECIALIZED SKILLS OR EXPERIENCE:

    • Proven ability to directly lead and/or co-lead multiple tasks and projects.
    • Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices).
    • Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
    • Ability to work with distributed and international teams.
    • Strong collaboration, negotiating, and conflict resolution skills.
    • Fluid verbal and written communication skills.
    • 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.
    • 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, 62304 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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    Design Quality Engineering Manager

    Medtronic
    North Haven, CT 06473

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