Senior Software Quality 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 Sr. Software Quality Engineer is responsible for defining, implementing, and delivering
effective and efficient software quality processes at Bigfoot Biomedical, a medical device start-up
company developing a diabetes management system product. This is accomplished through
leading, performing and supporting software quality engineering responsibilities within the design
and development lifecycle (i.e. from the initial requirements phase and continuing through the
deployment phase). Additionally, the position assists in establishing, supporting, and maintaining
the Quality Management System (QMS) procedures associated with software development.
This position is highly visible and works in cross-functional teams to support software
development and its integration into system hardware while insuring compliance to all 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

    • Represent QA to support software development projects.  
    • Establish and maintain the software quality assurance programs, processes, procedures and controls to ensure compliance with FDA Regulations and established industry standards. 
    • Be the Subject Matter Expert (SME) for design controls aligned with 21CFR 820, ISO 13485, IEC 62304 and ISO 14971 requirements. 
    • Ensure that product development projects and changes to existing products are conducted in compliance with the FDA, ISO Quality System Regulations, and Bigfoot SOPs.  
    • Provide guidance for establishing unambiguous software requirements, specifications, detailed designs, verification and validation, and planning documentation. 
    • Advise development engineers on software quality engineering concepts, principles and best practices 
    • Review and approve software and system related verification and validation plans, protocols, reports, backward compatibility matrices, and requirements traceability matrices. 
    • Participate in the software development activities, including design and code 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. 
    • Support validation testing for software based test tools utilized in the production or quality system processes.
    • Support design transfer activities to ensure validated software is successfully implemented in production and/or at the contract manufacturer.
    • Represent Software QA to support production sustaining activities, clinical testing, and field complaint.

    Must haves we’re looking for

    • Seven (7) or more years of in-depth quality engineering experience or equivalent. 
    • Minimum of three (3) years of experience in a software quality assurance role supporting medical devices that are FDA Class II or Class III; FDA Class III experience is preferred. 
    • Start-up 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. 
    • Working knowledge of various programming languages such as Swift/iOS, Java, C, Javascript, and Python. 
    • Experience with software quality for embedded systems consisting of custom software and software of unknown providence (SOUP). 
    • Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.). 
    • Experience with software used in design V&V, computerized systems validations, and process validations. 
    • 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. 

    We'd prefer if you also have the following:

    • 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 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 team player, excellent communicator, and comfortable in an entrepreneurial environment. 
    • Must be positive, energetic, and a strong advocate for product quality. 

    Education 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.