1+ months

Senior R&D Engineer - MDR Hazardous Substances

Mansfield, MA 02048
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Senior R&D Engineer - MDR Hazardous Substances


Mansfield, Massachusetts, United States

Requisition #:


Post Date:

Dec 02, 2019

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

**Position Overview:**

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

**Responsibilities Include:**

Assess RCS products for the risks of hazardous substances to meet MDR requirements.

Ensure RCS products meet the environment, packaging, and RoHS regulations. Assess alternative substances, materials or designs and analyze their availability and feasibility to meet the EU regulations.

Maintain a BU Hazardous Material database

Ensure EHSS requirements are met during Product Development Process and Sustaining Engineering updates

Ensure through analysis or physical testing the EHSS requirements are met

Capability of interrupting regulatory requirements to meet EHSS international requirements

Ensure that device concepts meet targeted geographies EHSS through systematic evaluation of product requirements of the system that acknowledge technical, schedule, and cost constraints.

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

Establish and advocate for best practices and continuous improvement of the Systems Engineering knowledge and processes (CoE)

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

Establish verification and validation plan(s) to ensure EHSS requirements are met

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

Assess system performance during the development process and provide feedback to these teams

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 system requirements

Provide engineering review on current research projects, device concepts and data.

Propose and champion new device concepts

**A Day in the Life**

Responsibilities may include the following and other duties may be assigned.

+ Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.

+ Designs studies to investigate specific life science questions within field of expertise.

+ May be involved in product research and development and/or clinical trials.

+ Translates research discoveries into usable and marketable products.

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

**Nice to Have**

Conversion of product concepts in product requirements

Solid understanding of the risk management process

Material sciences degree

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

Knowledge of dialysis device operation

Knowledge of FDA regulations and TV requirements

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

**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. Lets 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)
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.
Posted: 2019-12-05 Expires: 2020-03-13

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Senior R&D Engineer - MDR Hazardous Substances

Mansfield, MA 02048

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