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 student debt program and FreeU 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 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 10 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
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free cov erage 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
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.
Divisional Information
Medical Devices
General Medical Devices:
Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
CRM
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Diabetes
We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
Vascular
Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
Neuromodulation
Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.
Structural Heart
Structural Heart Business Mission: why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
EP
In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
HF
In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.
Diagnostics
We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on
Abbott’s diagnostics instruments, providing lab results for millions of people.
Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.
Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology.
Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.
Nutrition
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf