We believe that when people from different cultures, genders, and points of view come together, innovation is the result - and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. A Day in the Life Responsibilities may include the following and other duties may be assigned.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Performs and/or reviews process validation and equipment documents: URS, FAT, IQ, OQ, PQ, TMV
Applies basic statistical tools, preferably using Minitab, to assess compliance to product/process acceptance criteria.
Co llaborates in the implementation of new products/processes by proposing validation strategies to ensure Design requirements flow down into manufacturing controls
Inve stigates and/or collaborates in the investigation of manufacturing operations events to support product disposition.
Up dates and/or collaborates in process risks assessment documentation (e.g. pFMEA) aligned with Medical Devices regulations
Must Have: Minimum Requirements
Bachelors Engineering degree required
Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Nice to Have
Experience assessing and tracing manufacturing defects/rejects trends.
Experience working and executing Design transfer activities.
Experience with projects to implement new products: design requirements validation, manufacturing controls.
Capable of developing and executing test plans/protocols for new or modified manufacturing-related software.
Deve lops, reviews and approves software procedures.
D ebugs/troubleshoots software products through the use of systemic tests to develop, apply and maintain quality standards for company products.
Ensu res quality computer integration into overall functions of data acquisition, processing and storage.
Over sees all applicable compliance related to manufacturing software.
Admi nisters all manufacturing related software.
Capa ble of applying GAMP principles, ALCOA principles and applicable regulations (including Part 11) to ensure compliance of the medical device
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)
