Senior Human Factors Engineer

What is Bigfoot Biomedical?
 
Bigfoot believes people living with insulin-requiring diabetes deserve relief from its daily burden. We envision a world where the emotional, mental, physical, and financial burden of diabetes has been significantly reduced. We are passionately dedicated to delivering simpler, safer, and more effective solutions for life with insulin.
 
We are personally committed to the mission of improving the lives of people with diabetes through the application of smart technology. We bring deep and nuanced understanding of customer needs, demonstrated technical capabilities in developing and commercializing technology, and proven business acumen in funding and growing startups into profitable publicly traded enterprises.
 
What we are building at Bigfoot Biomedical
 
Bigfoot is building diabetes management solutions integrating data, software, smart devices, and people. This is your chance to join a small but very talented team!

Human Factors Engineer

The Senior Human Factors Engineer's primary purpose is to ensure that Bigfoot’s service offerings, including software applications, devices, associated labeling, packaging, and training (if applicable) are designed to be safe and effective for use by intended users within intended environments for all chosen markets. This is a senior role, responsible and accountable to implement a Human Factors strategy at Bigfoot Biomedical that meets regulatory guidelines and requirements for the US and EU markets.

What will you do at Bigfoot Biomedical?

 

What you do here at Bigfoot will largely be defined by your existing skills and desire to grow to help us achieve the above. We have an employee-friendly working environment that provides bike racks and showers, lunch and snacks, and flexible hours. Our culture helps us stay focused on our goals.
 
We have competitive benefits. We have a great team culture. We understand that we all need to succeed as a team. We have fun while we're building a solution we can be proud of.

 

If you're ready to make a dent in the universe, join the mission, and feel like what you do every day isn't just a job, come talk to us!

 

Bigfoot Biomedical, Inc., provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to 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.

    Essential Duties and Responsibilities:

    • Develop Bigfoot’s overall Human Factors Strategy to meet guidelines and regulations for the US and European markets

    • Develop the following Human Factors specific documentation and perform the following tasks:

    • Program specific Human Factors plans
    • Usability Specifications including User Profiles, Use Environments, Intended Use, Intended Training, etc.
    • Task Analysis and Use Error assessment to identify critical and essential tasks
    • Human Factors input into risk management activities, making sure Human Factors findings are appropriately reflected in Bigfoot’s risk documentation
    • Human Factors study feedback and recommended mitigations to the product teams
    • Reports of any adverse findings or adverse events witnessed at Human Factors studies to ensure appropriate action
    • In addition, this role will support:
    • The generation of regulatory submission data
    • Compliance of Human Factors deliverables with regulations and local procedures
    • Internal and external audits of Human Factors related aspects of the Quality System
    • Formative and conceptual Human Factors work

    Must haves we’re looking for:

    • 3-5+ years of Human Factors or relevant work experience
    • Experience working on FDA regulated, class 2 or class 3 medical devices
    • Understanding of Quality System Regulations (QSR), including maintenance of a Design History File
    • Strong interpersonal and communication skills in written and verbal form
    • Flexible and adaptable in a fast-paced, start-up environment
    • 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

    We’d prefer if you also have:

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

    Educational Requirements:

    • Bachelor’s Degree in human factors engineering, experimental psychology, cognitive psychology, industrial design or a related field.
    • Master's Degree in one of the above fields from an accredited university (preferred)