1+ months

New Product Verification and Compliance Manager

Medtronic
Rockwood, TN 37854
  • Jobs Rated
    25th
New Product Verification and Compliance Manager

Location:

Yokneam, Industrial Zone, HaTsafon, Israel

Requisition #:

2000037X

Post Date:

May 18, 2020


**Careers that Change Lives**


The New Product Verification and Compliance Manager position is one of development, improvement and innovation, if you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you.


As a New Product Verification and Compliance Manager you will be responsible for leading and overseeing the various software and hardware verification and validation activities associated with supporting the release of medical device products and processes for the Gastrointestinal business in Medtronics Gastrointestinal Hepatology division. This position, based in Yokneam, shall manage quality and compliance activities of complex multi-disciplinary medical state of the art devices. The VV team led by this position is responsible for management of design control activities and the verification and validation of these products. This includes the development of system test plans, procedures and reports, the update to risk management documentation, and the review of trends found in the monitoring devices after release.


**A Day in the Life**


As part of your day to day you will:


Lead a team of VV engineers to support all design control, hardware and system verification testing activities for gastrointestinal medical devices.


Participate in design reviews and requirement reviews to develop thorough test designs and test cases for complete test coverage.


Plan and strategize for test design and test procedures to ensure complete functional and non-functional test coverage for multiple projects concurrently.


Establish VV framework to support positive, negative and boundary testing and develop test automation where practical.


Develop Verification and Validation plans. Established test strategy and tactics on assigned projects and ensure full execution of the strategy


Create and Execute exploratory, functional, regression, system, performance and reliability tests according to established verification plan in test environment for SW, electrical, mechanical and packaging (if any)


Report defects and assist developers in reproducing defects and assist in finding the cause to various defects. Define processes for early detection of defects within Software Development Life Cycle (SDLC).


Ensure the project meets the test entrance criteria before testing commence and test exit criteria before the project release. Define key progress indicators from testing perspective and provide regular test summary dashboard to all key stakeholders


Create traceability matrix report between test cases, requirements and design. Provide timely communications on significant issues or risks identified in testing and provide risk mitigation planning where applicable.


Create and maintain risk management files including preliminary risk analysis, failure mode effect analysis, risk evaluation, mitigation and overall risk acceptability.


Establish process pertaining to design controls, VV, risk management and other associated


**Must Haves**


BSc in Engineering with strong background in electronics


8 years of progressive VV management responsibility with at least 4 years in the medical device industry, or equivalent work experience and/or professional qualifications


Working knowledge of, and auditing experience to, the FDA Quality System Regulation, ISO 13485, IEC 62304, and the EU Medical Device Regulation.


Experienced in product risk management to the requirements of ISO 14971.


Skilled in statistical methods, statistical process control and sampling plans


Familiar with reliability analysis and test methods


Working knowledge of IEC 62304


**Your Answer**


Is this the position you were waiting for? Then please apply directly via the apply button!


**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.


Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.


**PHYSICAL 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. 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.
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.

Categories

Jobs Rated Reports for Compliance Officer

Posted: 2020-03-03 Expires: 2020-06-25

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Medtronic
Rockwood, TN 37854

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Compliance Officer
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Overall Rating: 25/220
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