Sr Quality Engineer - Risk Management
Northridge, California, United States
6 hours ago
**Careers That Change Lives**
Plan, coordinate, and execute medical device international standards compliance activities to ensure the compliance, safety and reliability of Medtronic Diabetes products throughout the lifecycle of the product (from concept to end of life).
Support the development of state of art, Medtronic Diabetes Standards Engineering program and systems for both pre-market and post-market.
Serve as subject matter expert (SME) for the Risk Management Engineering processes.
Coach and provide direction to junior Engineers and cross functional teams regarding Risk Management Engineering processes and best practices.
Transforming diabetes care together, for greater freedom and better health.
Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Visit www.medtronicdiabetes.com at http://www.medtronicdiabetes.com/ to see an overview of the products in our Diabetes product portfolio.
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
+ Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
+ Collaborates with engineering and manufacturing functions to ensure relevant and appropriate quality standards are in place.
+ Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
+ Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
+ Owns, improves, and implements risk management-related procedures to match current state-of-the-art industry practices.
+ Executes risk activities including Risk analysis, Design FMEA, Process FMEA and Software FMEA, and Design Controls.
+ Application of ISO quality system ISO13485, ISO 14971, US FDA Quality System Regulation (21 CFR 820), EU Medical Device Directive and relevant international standards
+ Participates in maintaining, improving and evolving our medical device product development, complaint handling, and vigilance processes
+ Analyzes production and post-market data to identify changes to product/system risk profiles
+ Facilitates pre-production risk assessments for new product development programs and conducts post-production risk assessments/Issue Impact Assessments (IIAs) for field issues for current on-market products
+ Supports manufacturing operations including process changes, design changes, new materials and new component engineering change orders
**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 Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.
**Nice to Have (Preferred Qualifications)**
+ Working knowledge of ISO quality system (ISO13485), US FDA Quality System Regulation (CFR 820), EU Medical Device Directive and EU Medical Device Regulation or equivalent and relevant international standards.
+ Knowledge of IEC 60601 series of technical standards.
+ Hands on experience in risk management tools and methodologies
+ Experience in developing system and product requirements based on needs identified during risk management activities
+ Masters of Science Degree in an Engineering or Science-related field.
+ Experience within the medical device industry.
+ Ability to write technical reports, business correspondence, technical procedures as well as administrative procedures that are clear and usable to maintain substantial compliance.
+ Good understanding of medical device product development processes.
+ Self-starter and accountable, with sharp focus on quality and customer experience.
+ Effective influencing skills, including building rapport with internal customers.
+ Ability to represent the department in frequent intra and inter-organizational events.
+ Ability to provide solutions to difficult technical issues associated with specific projects.
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)
Travel up to 10% domestic and international.
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.