Senior Design Assurance 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!

The Senior Design Assurance Engineer will be part of the Design Assurance team responsible for ensuring that Bigfoot’s system verification & validation strategies and testing are comprehensive, with the goal to release safe, effective and reliable system products that delight the end-users that include people with type 1 diabetes, their family members, and physicians. The Design Assurance team plays a critical role in system design and requirement analysis to guide engineering teams toward designs that can be thoroughly tested and toward automated testing that can be applied at both the system and component (hardware and software) levels. The Design Assurance team is also responsible for designing test tools, performing tool validation, writing verification test cases, and performing testing.
 
This position is highly visible and works with other cross-functional teams to support software development and its integration into system hardware while ensuring compliance to all applicable regulatory requirements.
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:

    • Lead the Design Assurance team for system level verification of both Bigfoot’s infusion pump-based automated insulin delivery system and Bigfoot’s connected injection system.
    • Provide guidance for establishing good requirements, specifications, detailed designs, verification and validation, and planning documentation.
    • Advise development and junior DA engineers on design assurance engineering concepts, principles, and best practices.
    • Develop software, hardware, and system related verification and validation strategy for the R&D organization and ensure the execution of the strategy
    • Participate in software development activities, including design reviews, requirements analysis and tracing, defect tracking, and software configuration management.
    • Support the risk management activities for software and systems in compliance with ISO 14971 and software risk requirements in IEC 62304.
    • Contribute to the design and process Failure Mode Effects Analysis (DFMEA & PFMEA) and System Hazard Analysis activities.
    • Specify and execute validation testing for test tools utilized in the product verification.
    • Ensure that product development projects and changes to existing products are conducted in compliance with the FDA, ISO Quality System Regulations, and Bigfoot SOPs.
    • Develop automated test framework, automated test scripts, test plans, and test cases based upon the product and component level requirements.
    • Ensure that product development and verification tests developed are in compliance with the FDA, ISO Quality System Regulations, and Bigfoot SOPs.

    Must haves we're looking for:

    • Minimum of five (8) years of experience in a design assurance role supporting medical devices that are FDA Class II or Class III; FDA Class III experience is preferred.
    • Startup or small company experience is desirable.
    • In depth working knowledge of US FDA Quality System Requirements, ISO 13485, ISO 14971, and IEC 62304. Experience with supporting regulatory audits and FDA inspections is a plus.
    • Experience with system thinking for electromechanical and embedded systems consisting of custom hardware, software and software of unknown provenance (SOUP).
    • Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
    • Experience with developing test strategy for integration of system components.
    • Working knowledge of Agile Software Development methodologies and associated development tools (SCRUM, Jira, Jama, Confluence, codeBeamer) is highly desirable.
    • Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
    • Knowledgeable about QA methodologies related to regression testing, ad hoc testing, functional testing and verification of calculations, user interface testing, and integration testing.
    • Skilled in test plan development and root cause failure analysis.
    • Strong verbal (including presentation) and written communication skills, especially technical report writing.
    • Strong verbal (including presentation) and written communication skills, especially technical report writing.

    We'd prefer if you also have:

    • Strong leadership skills to manage the organization and influence a cross-functional, matrix R&D organization
    • Excellent analytical and problem solving skills
    • Motivated self-starter with the ability to work independently and collaboratively
    • Must be able to follow established policies and procedures, create new processes and procedures, and comply with regulatory requirements.
    • Ability to recognize problems and recommend/implement solutions.
    • Must be comfortable and able to work well in a fast-paced environment. This requires the candidate to be flexible and have the ability to juggle multiple projects at a time.
    • Individual must be hands-on, results-oriented, who is a strong leader and team player, excellent communicator, and comfortable in an entrepreneurial environment.
    • Must be positive, energetic, and a strong advocate for product quality.

    Educational Requirements:

    • Bachelor’s Degree (BS) in Computer Science or an engineering discipline. 
    • Master’s Degree (MS) is desirable.
    • ASQ (e.g. CQE, CRE, or CSQE) certifications or other software quality certificates are desirable.