UnitedHealth Group is hiring

Risk Management Engineer (Medical Devices) - Telecommute job at UnitedHealth Group, Indianapolis

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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's improving the lives of millions. Here, innovation isn't about another gadget, it's about making health care data available wherever and whenever people need it, safely and reliably. There's no room for error. Join us and start doing your life's best work.(sm)

You’ll enjoy the flexibility to telecommute* from anywhere within United States as you take on some tough challenges.

Primary Responsibilities:

  • Demonstrate expertise in development of risk management plans
  • Maintain/update risk management reports for medical devices
  • Demonstrate high level of competency in leading and facilitating risk management meetings with cross-functional teams (Product Management, Clinical, Software Development, Quality Assurance, Regulatory)
  • Create/update risk analysis for new and existing products, including review of both hardware and software
  • Focus on Risk Management activities related to the review of Non-conformances, Complaints, CAPA
  • Support Lifecycle Risk Management activities and manage Process/Design FMEAs across multiple product lines
  • Perform impact assessments for change control activities related to design change
  • Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements
  • Manage QMS updates to relevant SOPs/WIs/Forms,
  • May contribute to the development of policies and procedures
  • May act as a mentor to less experienced colleagues
  • 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:

  • Bachelor’s degree in engineering or science field or equivalent experience
  • 5+ years of experience in medical device industry with knowledge of FDA regulations
  • 3+ years quality systems experience 21 CFR Part 820 
  • 3+ years of project management
  • 3+ years proven work experience supporting lifecycle risk management activities and managing use, process, and design FMEAs across multiple product lines
  • 3+ years of experience working with Six Sigma methodology (DMAIC, 5 Whys, Fishbone Diagram, etc.) for root cause analysis
  • Full COVID-19 vaccination is an essential requirement of this role. Candidates located in states that mandate COVID-19 booster doses must also comply with those state requirements. UnitedHealth Group will adhere to all federal, state and local regulations as well as all client requirements and will obtain necessary proof of vaccination, and boosters when applicable, prior to employment to ensure compliance

Preferred Qualifications:

  • Thorough understanding of FDA regulations, ISO 14971:2019 or previous version
  • Demonstrates understanding and/or application of Design Controls, Process Validation, Risk Management, and Change Control
  • Demonstrates understanding and application of statistical techniques, quantitative and qualitative, to facilitate design and process analysis, including improvements
  • Technical writing skills, interpersonal skills

To protect the health and safety of our workforce, patients and communities we serve, UnitedHealth Group and its affiliate companies require all employees to disclose COVID-19 vaccination status prior to beginning employment. In addition, some roles and locations require full COVID-19 vaccination, including boosters, 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)

Colorado, Connecticut or Nevada Residents Only: The salary range for Colorado residents is $82,100 to $146,900. The salary range for Connecticut / Nevada residents is $90,500 to $161,600. Pay is based on several factors including but not limited to education, work experience, certifications, etc. 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.

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

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 country: United States

City: Indianapolis

Category: Electronics Engineers, Except Computer

Location: Indianapolis, IN, United States

Job posted 2022-06-04

This job is expired

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