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1+ months

Principal Systems Engineer - Surgical Robotics

Medtronic
Boston, MA 02133
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Principal Systems Engineer - Surgical Robotics

Location:

Boston, Massachusetts, United States

Requisition #:

220004WA

Post Date:

Mar 16, 2022


**Careers that Change Lives**


You will join a team of mechanical, electrical and software engineers responsible for developing Medtronics Robotic Assisted Surgery Advanced Instrumentation from concept development through commercialization.


Medtronic is intensely focused on creating a workplace environment that reflects our standing as the worlds top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business.


**Impact patient outcomes. Come for a job, stay for a career.**


The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, fastercomplication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.


SURGICAL INNOVATIONS set the standard for Minimally Invasive Surgery (MIS) by creating innovative surgicalproducts 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**


In this exciting role as aLabeling Specification Specialistat MedtronicsBoston, Massachusettslocation, you will be responsible for supporting the development of medical device labeling for the Surgical Roboticsbusiness by coordinating across functions as well as with multiple US and international sites. You will provideproject support and orchestration of labeling development activities interfacing with Marketing, RD, Regulatory, Technical Communications, Legal, Quality and Package Engineering, site Operations, and other relevant business partners.


+ Leadcross-functional collaboration and influencethe scope of changes and labeling requirements.

+ Owndevelopment of the Labeling Plans and related documentation in accordance with overall project implementation plan.

+ Coordinateproject plan for labeling activities to meet timelines and provide inputs and supportoverall project plan based on label development requirements

+ Clearly communicate product and project requirements to the labeling design team to ensure timely and accurate execution of key deliverables.

+ Reviewproduct labeling including labels, cartons, IFUs and other related materials ensuring that they meet all business, medical, legal, and regulatory requirements and standards for medical devices.

+ Managethe review and approval process for all new and revised labeling content.

+ Understands applicable global labeling regulations and standards.

+ Coordinatethe translations of non-IFU labeling through internal or external sources.

+ Provide input in the creation of and compliance with standards and documented procedures for labeling development, revision and overall document management.


**Must Have: Minimum Requirements**


+ Bachelors degree required

+ Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience


**Nice to Have**


+ Minimum of 7 yearsexperience in packaging, labeling or relevant regulated industry

+ Experience managing complex projects on cross-functional teams

+ Highly detail-oriented

+ Experience working in business systems including Excel and other Microsoft Office programs

+ Comfortable learning and using new computer systems and program

+ Experience working in the medical device, Pharmaceutical or related industry


**Working Conditions:**


+ Remote work from home and standard office setting

+ Based in Boston, Massachusetts, USA

+ Infrequent travel may be required


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies andservices can do to help alleviate pain, restore health and extend life. We challenge ourselves and each otherto 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 withthe right people on our team. Lets work together to address universal healthcare needs and improve patientslives. 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)


**EEO**


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 regardto public assistance, veteran status, or any other characteristic protected by federal, state or local law. Inaddition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


This employer participates in the federal E-Verify program to confirm the identity and employment authorizationof all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees
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.

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Posted: 2022-03-18 Expires: 2022-05-27
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Principal Systems Engineer - Surgical Robotics

Medtronic
Boston, MA 02133

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