Quality Management Engineer - Design Controls - National Remote - 2282126

UnitedHealth Group; Minnetonka (MN); Remote; Confidential; Full time

Job summary

An innovative organization is seeking a Quality Management Engineer to ensure the implementation of a robust Quality Management System. This role involves working closely with cross-functional teams to uphold quality standards throughout the software product lifecycle. You will engage in design controls, analyze product quality metrics, and support risk analysis. This position offers the flexibility to telecommute from anywhere in the U.S., providing a unique opportunity to contribute to impactful health solutions. Join a team dedicated to improving health outcomes and advancing equity in healthcare.

Benefits

Comprehensive benefits package

Incentive and recognition programs

Equity stock purchase

401k contribution

Qualifications

• 5+ years experience in Software as Medical Device.
• 3+ years experience with FDA QSR, ISO 13485, IEC 62304.

Responsibilities

• Ensure product line’s adherence to Regulations and Quality Management System.
• Develop and manage quality plans for the products.
• Support product risk analysis and complaint monitoring.

Skills

Software as Medical Device

FDA Quality System Regulation (QSR)

ISO 13485

IEC 62304

Agile Software Development

Data Analysis

Creative Problem-Solving

Attention to Detail

Excellent Communication

Leadership Skills

Education

High School Diploma/GED

Bachelor’s Degree in Engineering, Computer Science, Information Technology or Biomedical Sciences

Job description

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to startCaring. Connecting. Growing together.

Optum is redefining how consumers and business customers interface with healthcare products and services.Critical to this are the innovative products and services being developed by the newly formed Optum Insight Clinical Decision Support (CDS) team.Themission of the OI CDS team to deliver clinical solutions that delivers quadruple aim objectives and build trust with users.

The Quality Management Engineer – Design Controls will be a key player to ensurethe OI CDS team implements the ‘fit for purpose’ Quality Management System. In this role you will closely work with cross functional teams to ensure that the right activities are done at the right time across entire software product lifecycle. You will implement design controls, analyze product quality metrics, support product risk analysis, support complaint monitoring, and trainings.

We are looking for someone that has experience with Software as Medical Device, has business orientation and comes up with pragmatic solutions.

You will enjoy the flexibility to telecommute* from anywhere within the U.S. as you take on some tough challenges.

Primary Responsibilities:

• Ensure product line’s adherence with relevant Regulations, Standards and Quality Management System processes
• Handhold product team members in establishing Design History File (Engineering File) and ensure its completeness
• Develop and manage quality plans for the products
• Review engineering deliverables and provide feedback
• Conduct milestone reviews for the products
• Support in product risk analysis, evaluation, control, residual risk evaluation, and post productions monitoring
• Support designated complaints handler in monitoring & tracking of complaints
• Develop and deploy the trainings on relevant quality topics
• Participation in corrective & preventive actions and quality audits
• Drive process improvements in collaboration with the cross-functional teams
• Work closely with cross functional teams to promote a culture of quality and safety within the product line
• Analyze product quality metrices, report and escalate the deviations to all relevant stakeholders for timely interventions

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:

• High School Diploma/GED (or higher)
• 5+ years of experience in the Software as Medical Device (SaMD)
• 3+ years of experience with FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485 and IEC 62304

Preferred Qualifications:

• Bachelor’s Degree preferably in Engineering, Computer Science, Information Technology or Biomedical Sciences
• Demonstrated experience with EU MDR, and ISO 14971
• Experience in Agile Software Development and Medical Device Life Cycle Management
• Experience in Clinical Decision Support, Software as Medical Device and Medical Device Life Cycle Management
• ASQ Software Quality Engineer certification
• Hands-on experience in implementing a quality system in a product line
• Ability to multi-task and prioritize responsibilities
• Excellent attention to detail
• Excellent verbal and written communication
• Creative problem-solving skills
• Data analysis and statistical aptitude
• Good interpersonal skills
• Strong leadership, collaboration skills and ability to thrive in a dynamic environment

*All Telecommuters will be required to adhere to UnitedHealth Group’s Telecommuter Policy.

The salary range for this role is $89,800to $176,700annually based on full-time employment. Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. UnitedHealth Group complies with all minimum wage laws as applicable. In addition to your salary, UnitedHealth Group offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with UnitedHealth Group, you’ll find a far-reaching choice of benefits and incentives.

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Application Deadline:This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location, and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups, and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission.

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 Groupis a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

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