Job Description

MEDTRONIC

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations

OUR PURPOSE

At our Design Quality department in Medtronic, plc, we focus on providing Engineering support for Quality Compliance and Risk Management activities, across the Ventilation portfolio. As a Senior Electrical Design Quality Engineer, you will support the application of Design Controls in the development and support of Respiratory products, through the participation in design verifiation requirements, conducting risk management reviews and ensuring that all design changes are compliant to associated Regulations and Methods.   

Come for a job, stay for a career!

A DAY IN THE LIFE OF:

Responsible for ensuring that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations and EU MDD / MDR requirements.

Responsible for reviewing new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.

Participate on cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA and Risk Management Report) and facilitate Post Launch Risk Management Reviews.

Participate in the development of Design Verification and Validation test plans / protocols and provide guidance on Product Requirements compliance. Participate in engineering Design Reviews.

Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.

Provide training to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods and design controls), when necessary.

Provide Quality support to facilitate the rapid resolution of Product Complaints and/or Patient Safety issues.

Review Design History Files and Technical Files for conformance to applicable requirements and support the Regulatory Department in reviewing technical submissions. 

Must Have: Minimum Requirements

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

Nice to Have

BSEE
Experience with “Product Lifecycle Management (PLM) software
Experience in development of and /or approval of PCB/PCBA documentation.
Experience in creation and/or approval of Engineering change orders.
Experience in creation or approval of product requirement specifications.
Experience with FDA and International Regulatory agency requirements, CE marking (MDD / MDR).
Knowledge and Experience in developing and manufacturing medical devices in conformance with Quality System Regulation, ISO13485 and ISO 14971 requirements.
Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills and interpersonal skills.
Ability to effectively manage multiple projects and priorities. Experience working with cross-functional teams.
Proficient skills with MS Word, MS Outlook, MS Excel.

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)