Edwards Lifesciences

Sr Principal Engineer, Human Factors

USA - California – Irvine Full time

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

How you’ll make an impact:

This Senior Principal Human Factors Engineer role is a unique opportunity to foster and support human factors and usability engineering activities with new product development and commercial teams across projects and business units, for both physical and digital devices. This is a high visibility and high impact career opportunity.

  • Support patient-first corporate strategy by applying knowledge of human factors engineering requirements and best practices to minimize use-related risk, improve user experience, and achieve device and system clinical success.
  • Provide design guidance and solutions to highly complex usability issues for both physical and digital devices.
  • Engage and influence business unit and project team leadership to support human factors and usability engineering activities throughout the product development process.
  • Partner with clinical, quality, regulatory, marketing, and R&D functions from multiple project teams to promote and execute best practices in human factors and usability engineering, identify and mitigate use-related risks, and ensure compliance with internal requirements and external regulations and expectations.
  • Initiate and lead in the design, planning, and execution of usability research and evaluations, analyze results, identify risk mitigation and design improvement recommendations, and communicate findings and recommendations to the team.
  • Document results of usability evaluations and other usability engineering process deliverables, including usability engineering plans, protocols, reports, team debriefs, design reviews, etc.
  • Identify opportunities to improve product usability by engaging with clinicians and other device users to collect user feedback (both objective and subjective) on devices.
  • Lead the development of new and complex human factors evaluation methods and technologies.
  • Provide creative solutions to alleviate complex usability problems.
  • Maintain current knowledge of human factors and usability regulations, expectations, and best practices.
  • Mentor, coach, and guide employees on usability processes and best practices.
  • Some domestic and international travel (5-10%).

What you'll need (Required):

  • Bachelor’s degree with 8 years of experience OR a Master's degree with 7 years of experience OR a PhD with 4 years of experience.
  • Suitable undergraduate and/or graduate degrees include human factors engineering, mechanical engineering, biomedical engineering, or a related engineering/science discipline.

What else we look for (Preferred):

  • Experience in the medical device or other highly regulated industry is required.
  • Human factors / usability engineering experience is required.
  • UI/UX design experience is highly desirable.
  • Experience planning and executing human factors studies utilizing various methodologies such as ethnographic research, contextual inquiry, cognitive walk through, heuristic analysis, task analysis, simulated use studies, and summative testing.
  • Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources. Ability to be collaborative and flexible in approach to solving user interface related challenges.
  • Effective communication, listening, and root cause analysis skills are required to interface with health care professionals and cross-functional team members.
  • Ability to clearly communicate how study results can be implemented into design, including analyzing and synthesizing large quantities of information into usable content for project teams and the business.
  • Must be proactive and creative in solving technical problems.
  • Strong documentation and organizational skills.
  • Must be a dynamic team player and a highly motivated self-starter able to achieve results independently and through cross-functional collaboration.
  • Demonstrated ability to present to and interact with senior leadership.
  • Experience with medical implantable devices is highly desirable.
  • Figma experience is highly desirable.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.