Combine two of the fastest-growing fields on the planet with a culture of performance, collaboration and opportunity and this is what you get. Leading edge technology in an industry that is improving the lives of millions. Here, innovation is not about another gadget; it is about making health care data available wherever and whenever people need it, safely and reliably. There is no room for error. If you are looking for a better place to use your passion and your desire to drive change, this is the place to be. It's an opportunity to do your life's best work.(sm)
Design Quality Engineering is responsible for product and service quality planning, evaluation and control. Works cross-functionally in the development and implementation of prevention-based methodologies used in design, manufacturer, test, sustainability and correction of products and services. Works on design quality assurance activities related to new product development and new business development, ensuring compliance with regulatory and company requirements.
Primary Responsibilities:

• Demonstrate knowledge of risk management activities, create and/or update RMR as necessary
• Perform impact assessments for Change control activities related to design change
• Must be proficient with Design Control requirements per 21 CFR Part 820
• Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements
• Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements
• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
• May contribute to the development of policies and procedures
• May act as a mentor to less experienced colleagues
• Demonstrates understanding and application of statistical techniques, quantitative and qualitative, to facilitate design and process analysis, including improvements
• Demonstrates understanding and/or application of Design Controls, Process Validation, Risk Management, and Change Control
• Ensures appropriate engineering and scientific analyses and rationales are employed

You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
Required Qualifications:

• Undergraduate degree (engineering preferred) or equivalent experience
• 2+ years of experience in FDA regulated industry (medical device or pharmaceutical)
• 2+ years of experience in design quality engineering
• Full COVID-19 vaccination is an essential requirement of this role. UnitedHealth Group will adhere to all federal, state and local regulations as well as all client requirements and will obtain necessary proof of vaccination prior to employment to ensure compliance

Preferred Qualifications:

• R&D, New Product Development, or Design Quality Engineering experience following Design Controls
• Operations experience as a Manufacturing or Quality Ops engineer
• Supplier Quality Engineering experience, which includes experience with Supplier Quality Agreements and Component qualifications
• Excellent attention to detail, hands-on engineering experience, and passionate about quality

To protect the health and safety of our workforce, patients and communities we serve, UnitedHealth Group and its affiliate companies now require all employees to disclose COVID-19 vaccination status prior to beginning employment. In addition, some roles require full COVID-19 vaccination as an essential job function. UnitedHealth Group adheres to all federal, state and local COVID-19 vaccination regulations as well as all client COVID-19 vaccination requirements and will obtain the necessary information from candidates prior to employment to ensure compliance. Candidates must be able to perform all essential job functions with or without reasonable accommodation. Failure to meet the vaccination requirement may result in rescission of an employment offer or termination of employment.
Careers with Optum. Here's the idea. We built an entire organization around one giant objective; make health care work better for everyone. So when it comes to how we use the world's large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life's best work.(sm)
Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.
UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment
Job Keywords: Design Quality Engineer, Quality Engineer, Design Engineer, Engineer, Plano, Texas, TX