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Labeling Specification Specialist

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Quality
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1900037Z Requisition #
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MEDICAL DEVICE LABELING SPECIALIST

 

Careers that Change Lives

 

Help streamline and speed our time to market and build quality in at every step.  You will be a member of the new product development team that supports the design and development of innovative, new products within the Renal Care Solutions business. You can apply advanced technical concepts to complex problems from concept generation through early phase development.

 

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

 

A Day in the Life

Medical devices can be complex and may require users to understand specific information about storage, use, disposal, or reprocessing. Although it is optimal to guide the use of devices via intuitive design to the greatest extent possible, Medtronic has to rely on instructional materials to convey important information supporting safe and effective product use. Instructions for use (IFU) are therefore considered part of the product user interface.

The design needs of instructional materials are the same as the design needs for any product. Good design incorporates an understanding of a product’s real-life use.

You can do so through a combination of techniques, such as focus groups, interviews, field research, contextual inquiries, and literature reviews.

Designing usable IFUs involves selecting appropriate textual content, layout, organization, font, font size, contrast, and use of graphics.

You can provide engineering leadership in the design and development of innovative products for Renal Care Solutions through product level evaluation, verification and validation. You can provide engineering expertise on cross-functional development project teams and collaborate with other Medtronic and external engineering groups.

 

Responsibilities Include:

               Assess Labeling Regulatory Requirements for Medical Devices.

               Ensure Labeling Requirements for Specific Devices.

               Maintain good manufacturing practice labeling requirements.

               Solve and reducing Labeling issues and increase product quality.

               Ensure that device concepts meet targeted geographies Standard


 

 

Regulations through systematic evaluation of product requirements of the system that acknowledge technical, schedule, and cost constraints.

               Lead, coordinate, execute, and document labels analysis and design activities, including but not limited to security, safety, reliability, risk, usability and interface management

               Generate and approve requirements and specifications for all labeling aspects of product; ensure that all systems are developed in harmony and support each other.

               Apply established SOP's, and/or develop new processes as needed, to ensure that newly developed devices meet established requirements and, where necessary, are approvable under applicable regulatory requirements

               Collaborate with quality and regulatory colleagues to ensure compliance.

               Participate in the identification and resolution of complex system issues through interfacing with engineers representing other components.

•               Collect, analyze, and model design inputs (voice of the customer, voice of the business, etc.) and transform them into high quality stakeholder and labeling product requirements.


Must Have: Minimum Qualifications

3+ years of experience with a Bachelor’s Degree in a technical/engineering discipline; or

2+ years of experience with a Master’s Degree in a technical/engineering discipline; or

1+ years of experience with a PhD in a technical/engineering discipline

Graphic and artwork education

Knowledge of Corel Draw, InDesign, Photoshop or Illustrator programs

Fluent knowledge of English

 

Nice to Have

Other languages knowledge

Readiness for action and flexibility

Team spirit and resistance to stress

Strong orientation to the result and attitude to work in a precise and reliable way

Excellent organizational and communication skills

Significant breadth of knowledge in Quality, technical expertise, and all areas of product development.

Knowledge of dialysis device operation

Knowledge of FDA regulations and TÜV requirements

Knowledge of Medtronic engineering resources/groups and track record of collaboration.

Knowledge:

Device Labeling Guidance #G91-1

CFR - Code of Federal Regulations Title 21, PART 801  LABELING

ISO 15223-1:2016 Medical devices

ISO 7000:2014

BS EN 1041

 

 

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.

 


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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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