Senior Systems Design Assurance Engineer
Company: Bigfoot Biomedical Inc
Posted on: April 2, 2021
Senior Systems Design Assurance Engineer Milpitas, CA / PRODUCT
DEVELOPMENT - DESIGN ASSURANCE / 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 very talented team! The Senior
Systems Design Assurance Engineer is a 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. Essential Duties and
- Lead the Design Assurance team for system level verification of
Bigfoot's connected injection system.
- Provide guidance for establishing good requirements,
specifications, detailed designs, verification and validation, and
- 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
- Contribute to the design and process Failure Mode Effects
Analysis (DFMEA & PFMEA) and System Hazard Analysis
- 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
- Ensure that product development and verification tests
developed are in compliance with the FDA, ISO Quality System
Regulations, and Bigfoot SOPs. Qualifications:
- Minimum of five (5) 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
- Experience with developing test strategy for integration of
- 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
- 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
- Must be able to follow established policies and procedures,
create new processes and procedures, and comply with regulatory
- Ability to recognize problems and recommend/implement
- 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 Mechanical/Electrical or an
- Master's Degree (MS) is desirable.
- ASQ (e.g. CQE, CRE, or CSQE) certifications or other software
quality certificates are desirable. 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
Keywords: Bigfoot Biomedical Inc, Milpitas , Senior Systems Design Assurance Engineer, Other , Milpitas, California
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