Medtronic Sr Quality Engineer - Risk Management (Northridge, CA or Remote within the US) in Northridge, California
Sr Quality Engineer - Risk Management (Northridge, CA or Remote within the US)
Northridge, California, United States
Oct 14, 2021
Sr Quality Engineer Risk Management
Req Number 21000K36
Location Northridge, CA OR Remote within the US
Careers That Change Lives
In this exciting role as a Sr. Risk Management Engineer you will have responsibility for providing Risk Management expertise throughout the product life cycle including development, market release, and post-market activities within the Diabetes Quality organization. This includes evaluating product issues to ensure patient, user and security risk are assessed, and if applicable escalated for action.
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.
Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase.
Assess risks that were not previously identified, as well as potential risks associated with changes in therapy, systems, products, components, manufacturing processes,
Collaborate with Medical Safety and Complaint Handling to review and analyze field data, discuss the harm severity sources and estimate the probability or harm occurrence.
Author system and product level risk documentation with traceability for risk management files describing status of risk controls/mitigations.
Maintain risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation.
Actively communicate findings to Quality, Development, and Operations teams. and escalates when the risk profile of a medical device adversely changes.
Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings.
Develops, modifies, applies and maintains quality standards and protocol for risk management.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors Degree in Engineering, Science or technical field with 4+ years of experience in quality and/or engineering OR Advanced Degree in Engineering, Science or technical field with 2+ years of experience in quality and/or engineering
Nice to Have:
2+ years safety or systems engineering experience
Experience with ISO 14971:2019 and ISO TR 24971:2020-
Experience in Medical Devices
Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, analysis tools and methodologies to understand and quantify residual risks.
Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships
Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude
Ability to lead cross-functional teams and drive discussion and decision-making. This includes facilitation, consensus building and conflict resolution.
Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience), including presentation skills
High degree of initiative and self-motivation
Strong attention to detail and accuracy
Excellent organization skills; ability to successfully balance and prioritize multiple ongoingprojects/tasks
Strong analytical skills and the ability to solve problems through analytical reasoning.
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)
Occasional travel may be required.
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.