Labeling Specification Specialist (possibility of partial home office)
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.