Sr Design Quality Engineer Northridge CA or Remote within the US

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**Senior Design Quality Engineer**
**Req Number:** 220001DR
**Location:** Northridge, CA or Remote within US
**Careers That Change Lives**
In this exciting role as a Senior Design Quality Engineer, you will be a pivotal member of New Venture program and have the responsibility to work on the development of next generation Diabetes product. That includes developing quality plans, working on product/component specification, verification, and validation approach of the next gen product, along with supplier qualifications. Driving process and supplier risk analysis of the product including assessing-evaluating-mitigating patient safety risk and implementing risk control measures.
**NEW VENTURES**
Sr. Design Quality Engineer is a key member of the New Ventures team which is focused on developing new diabetes systems, products and solutions in an inorganic, accelerator environment. Our team is unique in that we can adapt to a variety of business, patient and marketplace needs that span the entire spectrum of our product portfolio today and in the future. Our mission drives the need to be a highly skilled, flexible, extremely efficient, versatile and agile in medical device product development for the benefit of our patients with Type 1 and Type 2 diabetes in need of intensive insulin therapy.
**Diabetes**
The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. Were committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease
**A Day in the Life**
**Responsibilities may include the following and other duties may be assigned.**
Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
Execute software verification activities.
Leads process validations (IQ/OQ/PQ), test method validations (TMV) and component qualifications.
Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
Completes risk analysis studies of new design and processes and provides inputs to the risk management. Analyze patient safety impact.
Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
Ensures that corrective measures meet acceptable reliability standards.
Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
As necessary, proposes changes in design or formulation to improve system and/or process reliability.
May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
**Must Have: Minimum Requirements**
**To be considered for this role, please ensure the minimum requirements are evident on your resume.**
Bachelor's Degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality.
**Nice to Have**
Masters degree preferred
Software Design Assurance Quality Engineering experience preferred.
ASQ-CQE, CSSGB, CSSBB or equivalent certifications
Experience in a highly regulated industry, preferably implantable medical devices
Knowledge and experience in application of statistics and lean sigma principles
Demonstrated ability to work in a matrix organization and positively influence strategy and outcomes
Ability to deliver on multiple projects simultaneously, and balance between long- and short-term priorities
Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools
Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others needs, negotiate for win-win, own the whole)
**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)
Up to 25% Travel domestic
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.
Categories
Healthcare
Engineering
Previous Job:
Account Representative Cranial & Spinal Technologies
Medtronic
Unspecified
Next Job:
Sr. Product Development Program Manager
Medtronic
Northridge, CA 91325 US
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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