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Abbott Senior Human Factors Engineer in Milpitas, California

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

  • Career development with an international company where you can grow the career you dream of.

  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

  • An excellent retirement savings plan with high employer contribution

  • Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree.

  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

As a Senior Human Factors Engineer, you will ensure the service offerings, including software applications, devices, associated labeling, and packaging are designed to be safe and effective for use by intended users within intended environments. This is a senior role with accountability and responsibility to implement a Human Factors strategy that meets regulatory guidelines and requirements for defined target markets.

This is an onsite daily opportunity in Milpitas, CA or Alameda, CA.

What You'll Do

  • Develop and execute overall Human Factors Strategy to meet guidelines and regulations for defined target markets.

  • Develop Human Factors specific documentation and perform the tasks in accordance with 62366 and FDA guidance documents (as well as other relevant standards) including, but not limited to:

  • Program specific Human Factors plans.

  • Use Specifications including User Group Definitions, Use Environments, Intended Use, User Needs, Intended Training, etc.

  • Task Analysis and Use-Related Risk assessment to identify critical and essential tasks.

  • Human Factors input into risk management activities, making sure Human Factors findings are appropriately reflected in risk documentation.

  • Human Factors study feedback and recommended mitigations to the product teams.

  • Human Factors Formative and Summative protocols and reports.

  • Reports of any adverse findings or adverse events witnessed at Human Factors studies to ensure appropriate action.

  • Generate regulatory submission data.

  • Ensure compliance of Human Factors deliverables with regulations and local procedures.

  • Participate in internal and external audits of Human Factors related aspects of the Quality System.

  • Execute and deliver formative and conceptual Human Factors work.

Education and Experience You'll Bring

Required

  • Bachelor’s Degree in an Engineering, Marketing, or a related field or an equivalent combination of education and work experience.

  • Minimum 6+ years of progressively more responsible work experience with the design of software for complex applications.

  • Requires in-depth knowledge and experience of: human factors as well as cognitive psychology theory and application; the software development process, software technology, and effective methods of working with R&D teams; customers, trends, governmental factors and emerging research and technologies affecting product usability.

  • A qualified record of implementing new processes to existing human factors and related systems.

  • Advanced computer skills including spreadsheet, word processing, database management, and specialized applications.

  • Experience working in a broader enterprise/cross-division business unit model preferred.

  • Ability to work in a highly matrixed and geographically diverse business environment.

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

  • Ability to leverage and/or engage others to accomplish projects.

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

  • Multitasks, prioritizes, and meets deadlines in timely manner.

  • Strong organizational and follow-up skills, as well as attention to detail.

  • Ability to travel approximately 10%, including internationally.

Preferred

  • Bachelor’ Degree in Human Factors Engineering, Experimental Psychology, Cognitive Psychology, Industrial Design, or a related field, with 5+ years of Human Factors and/or relevant work experience, or equivalent.

  • Master's Degree in one of the above fields from an accredited university (preferred).

  • Experience working on U.S. Food and Drug Administration (FDA) regulated, class 2 or class 3 medical devices or combination.

  • Knowledge of insulin-requiring diabetes / strong diabetes disease state and diabetes product knowledge.

  • Understanding of Quality System Regulations (QSR), including maintenance of a Design History File (DHF)/Usability Engineering File.

  • Strong interpersonal and communication skills in both written and verbal form.

  • Flexible and adaptable in a fast-paced environment.

  • Experience working as part of a cross-functional, multidisciplinary team.

  • Ability and desire to be proactive, a questioning mindset with a “can-do” attitude.

  • A creative thinker: one who looks for new and innovative ways of doing things.

Apply Now (https://www.jobs.abbott/us/en)

  • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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