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Engineering
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20000A3X Количество требований
Careers that Change Lives
This position will set strategy and coordinate the Medical Device Regulation and Regulated Substances program to ensure that Medtronic Diabetes BU have the programs, processes and systems in place to meet substance reporting and labelling obligations. This role will focus primarily on the EU Medical Device/In Vitro Diagnostics Regulations but will support other Regulated Substance requirements, such as California Proposition 65, as needed.

The Product Steward is responsible for assessing the applicable regulations for a device for the compliance with current and ongoing Global Product & Environmental requirements, including EU MDR, RoHS, REACH, WEEE, Prop-65, etc.

A Day in the Life
Has a deep understanding of materials/substances of concern (MOC) in medical device regulations (EU MDR, CFR 820), requirements set by regulatory bodies (FDA, EU notified bodies etc.), and international standards.   Provide chemical safety expertise to various regulatory compliance teams, e.g. EU MDR, Prop 65, REACH, etc. 
Independently determines task and steps related to MOC/medical device regulations applied to various  products. Plays an integral role in the strategy and tactical operations of the applicable regulations. Collaborate with cross-functional team to manage the broad range of compliance with regulations for various products. 
Guides and performs analytical testing for qualitative/quantitative characterization of extractable, leachable, and degradation products, in support of product development and sustaining commercial products. 
Familiarizes with cGMP lab regulations and operations. Maintains and strengthens a collaborative environment within the testing group and across cross-functional teams. Direct and train team to perform sample preparation, extraction, and separation to characterize key product attributes and resolve technical issues. 
Provides hands-on laboratory support and applies complete understanding of underlying Chemistry in work assigned and performed. Applies a broad range of knowledge in analytical technologies (e.g., FTIR, ICP/MS, GC/MS, LC/MS).
Educates internal/external teams in the area of biological safety evaluations, toxicological risk assessments, and chemical characterization. Demonstrates strong written/verbal communication skills including presentation skills. Has ability to tailor the information to the audience and answer with confidence and authority scientific questions
Create technical reviews and other mandatory documents for regulatory submissions
Update department technical procedures, work instructions, and other documentation as required 
Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings
Be professional, concise, and sensitive in accomplishing objectives. Be able to diplomatically negotiate with a requester regarding what they want in design, process, scope or timetable
Responsibilities may include the following and other duties may be assigned.
Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; supplier related engineering changes and optimizing device production relative to cost constraints.
Assumes responsibility for device and/or internally produced or externally purchased components after transfer into high-volume production and usually responsible for entire device manufacturing operations other than wafer fabrication.
May assist customer in device usage problems or customer testing of complex device
Must Have: Minimum Requirements
Education Required:
Minimum Bachelor of Science Degree in Science or Engineering

Years of Experience:
Bachelor of Science /Engineering with 7+ years or Master of Science/ Engineering with 5+ years experience in combined professional/academic research & development setting.

Nice to Have
Medical device and/or combination device experience
10+ years combined professional/academic research & development experience
Experience in user needs identification, specification development, risk assessments, testing, verification and validation.
Knowledge of Materials of Concern (MOC) regulations and standards
Biological evaluation & chemical characterization expertise
Excellent written and verbal communication skills
Enthusiastic, self-motivated, with a positive attitude to achieve personal and team goals
Knowledge of quality systems and regulatory submissions
Experience in healthcare industry supporting products that require pre-market approval (PMA)
Outstanding competencies as subject matter expert of biocompatibility and chemical characterization
Experience performing laboratory data interpretation including working with mathematical concepts relevant to the laboratory setting
Experience reading, analyzing, and interpreting common scientific and technical journals, scientific procedures and regulatory guidelines. 
Work successfully with diverse teams and individuals from varied disciplines
Experience coordinating work through outside service laboratories
Experience tracking multiple projects at various stages


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)

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