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Principal Human Factors Design Engineer

Company: Medtronic GmbH
Location: Boulder
Posted on: January 8, 2022

Job Description:

Help streamline and speed our time to market and build quality in at every step. You will be a member of the new product development team that supports the design and development of innovative, new products within Surgical Innovations business. You can apply advanced technical concepts to complex problems from concept generation through early phase development. Impact patient outcomes. Come for a job, stay for a career.
A Day in the Life
The Principal Human Factors Design Engineer is primarily responsible for user-centered research activities related to product design supporting Surgical Energy and Safety. With focus on instrumentation and system user interfaces, this position will support product development teams throughout the development lifecycle. This is an individual contributor role with opportunities for conducting user research, providing inputs related to human capabilities and product interactions for design, evaluating potential use errors for risk, performing usability assessments to inform design, and contributing to the verification and the validation of medical devices. Responsibilities may include the following and other duties may be assigned.

  • Planning, scaling, documenting, and executing human factors project activities
  • Work with cross-functional teams and provide Human Factors support through entire product development life cycle
  • Support early stage development with research, use studies and usability evaluations to identify user needs, support design optimization and identify potential use errors
  • Collaborate in ideation and conceptual design activities and presentations
  • Define and document workflows, user-related tasks and scenarios related to product use
  • Develop requirements related to use, user interactions and human performance
  • Evaluate and assess risks related to product use
  • Design usability evaluations to ensure user interface requirements are met, risk controls pertaining to use have been applied and are effective
  • Analyze data and report results, make recommendations for improvements based on Human Factors guidelines and best practices
  • Support process improvement and Human Factors related initiatives within the business
  • Applies human performance principles, methodologies, and technologies to the design of human-machine systems and products.
  • Develops and implements research methodologies and statistical analysis plans to test and evaluate developmental prototypes used in all phases of products development and processes.
  • Designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users.
  • Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized human-machine interfaces.
  • Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans. Must Have: Minimum Requirements
    • Bachelors degree required
    • Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
      Nice to Have
      • Bachelor's degree in Human Factors, Biomechanical Engineering, Biomedical Engineering, or related research-based discipline with minimum 7 years of related experience
      • Experience with Human Factors/Usability in medical devices and familiarity with existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance
      • Experience with Human Factors or User-centered design methodologies including generative research, user needs assessment, design concepts, and usability evaluations in support of product development
      • Experience with risk management activities applied by Human Factors to medical devices (e.g. UEA, AFMEA, UFMEA, URA techniques)
      • Confidence in user-facing activities and interacting with clinicians
      • Able to progress work independently with minimal supervision
      • Collaborations with multi-functional development teams
      • Process oriented with attention to detail
      • Strong written and verbal communication
      • Masters' degree in Human Factors or related field
      • Knowledge of the surgical environment
      • Experience with Combination products
      • Experience interacting with FDA and other regulatory bodies in the context of new product approval submissions and/or audits desired
        About Medtronic

        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) 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. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

Keywords: Medtronic GmbH, Boulder , Principal Human Factors Design Engineer, Engineering , Boulder, Colorado

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