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Sr. Systems Design Assurance Engineer


– Accepting applications

What is Bigfoot Biomedical?

Bigfoot believes people living with insulin dependent 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 will improve health and economic outcomes, make living with T1D easier and safer, reduce the support needed from medical professionals, and disrupt a broken industry riddled with ine­fficiency and ineffectiveness.

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 a Type 1 Diabetes (T1D) management solution integrating data, software, smart devices, and people. This is your chance to join a small but very talented team.

Sr. Systems Design Assurance Engineer

The Sr. System Design Assurance Engineer is responsible for ensuring that the system verification & validation strategies and testing are comprehensive to release safe, effective and reliable system products that delight the end-users that include type 1 diabetics and their family members and physicians. This position plays a critical role in system design and requirement analysis to guide engineering teams towards designs that can be thoroughly tested and automated testing can be applied in both system and component (hardware and software) level. Position is also responsible for designing test tools, perform tool validation, write verification test cases and perform testing as part of the Design Assurance team.

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 applicable regulatory requirements.

Essential Duties and Responsibilities:

  • Provide guidance for establishing good requirements, specifications, detailed designs, verification and validation, and planning documentation.
  • Advise development engineers on design assurance engineering concepts, principles and best practices.
  • Develop and execute software (or hardware) and system related verification and validation plans and protocols, and write test reports.
  • 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.
  • Specify and execute validation testing for test tools utilized in the product development.
  • Ensure that product development projects and changes to existing products are conducted in compliance with the FDA, ISO Quality System Regulations, and Bigfoot SOPs.

Must haves we’re looking for:

  • Five (5) or more years of in-depth design engineering or design assurance experience or equivalent.
  • Minimum of two (2) 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.
  • 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 system thinking 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.
  • Knowledgeable about QA methodologies related to regression testing, ad hoc testing, functional testing and verification of calculations, user interface testing, and integration testing.
  • 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.
  • 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:

  • 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.

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.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Combined sitting, standing and walking throughout the day to accomplish tasks.
  • Occasional reaching, stretching, pushing, pulling, stooping or crouching.
  • Manual dexterity used frequently with repetitive finger motion.
  • Occasional lifting up to 40 pounds.
  • Hearing and speaking required regularly.
  • Specific vision abilities include close and distance vision, depth perception, peripheral vision and ability to adjust focus.

Please note that this position may have exposure to bloodborne pathogens. Bigfoot Biomedical will comply with Cal-OSHA requirements and will provide vaccination, communication, and training of its Exposure Control Plan.

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 a Google-inspired working environment and culture to help 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!

Send an email introducing yourself and your resume to:

Please, no recruiters.

Job Perks

Amazing benefits and culture! Start-Up mentality (think gaming and ping pong room). Flexible Time Off, great medical benefits, equity incentive plan, company paid lunch every day and free snacks.

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