Software Quality Engineer

2 days ago

Carlsbad, United States DNA Electronics (DNAe) Full time

DNAe, the inventors of semiconductor-based next-generation sequencing (NGS) technology, is developing a revolutionary new platform that enables NGS-based diagnostic capability in an easy to use, cartridge-based system that will allow direct from clinical specimen to clinically relevant, actionable results in a matter of hours.


Job Description

We are seeking a strong individual to contribute to the DNAe team. The qualified candidate will be responsible for reviewing and ensuring that all software products meet the highest standards of quality and performance.


Responsibilities


  • Design, develop, and implement quality assurance standard operating procedures and processes for all software products to comply with regulatory bodies.
  • Review and approve test plans and test cases to ensure that software meets desired quality and performance standards.
  • Issue test record documents to perform software verification by software test engineer.
  • Develop requirement traceability metrics (from user requirements to functional requirements).
  • Review and approve software documentation for regulatory submission requirements.
  • Facilitate design input, design lock, software release ceremonies.
  • Review and approve software related risk documentation (Safety, Security, and Usability)
  • Establish metrics to measure quality and performance of existing and new software products.
  • Monitor and analyze software performance, user feedback, and defects to identify areas for improvement.
  • Work with product teams to ensure that software meets business and user requirements.
  • Review verification report at the end of each release
  • Review Software Bill of Materials (SBOM) to make sure all Software of Unknown Provenance (SOUP) tools or packages are up to date.
  • Own software related FDA 510(k) submission documents
  • Participate in the design and review of software architecture.
  • Keep up to date with industry trends and best practices.


Person Specification

We are looking for people with a passion for their work - people who strive for exceptional results, but who can deliver pragmatic solutions on time. DNA Electronics’ scientists and engineers enjoy and thrive on working in an interdisciplinary team but can also work independently and use their own initiative. The ideal candidate also likes to contribute to solving problems outside their field of immediate expertise and is an effective communicator.


Qualifications & Experience Required:


Bachelor’s Degree or equivalent in Computer Science, Engineering, or related field.


  • Moderate experience in software regulatory environment / medical device software development
  • Strong knowledge of IEC 62304, IEC 60601, ISO-IEC 80001, ISO 14971, ISO 13485, FDA 21 CFR Part 820.
  • Excellent decision-making skills, proficient in providing solutions for complex challenges and good problem-solving using quality tools.
  • Exceptional verbal, written and organizational skills and the ability to work effectively in a fast-paced, start-up environment.


Apply

If you believe you meet the above criteria and would relish playing a key role in developing a revolutionary technology, we would be delighted to hear from you.

We offer a competitive compensation package to successful candidates.

Please email your CV and cover letter to: HR-US@dnae.com quoting

Your name and the job title in the subject line.

For more information about DNAe, please visit our website


DNAe is committed to offering staff a competitive remuneration package, alongside compelling benefits. As the primary part of the process, we conduct a rigorous market data review where each role is individually benchmarked using a vast amount of recent data. The estimated base salary range for the Software Quality Engineer role based in Carlsbad, California is: $90,000 to $110,000. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly.


DNAe, Inc. is an equal opportunity employer that does not discriminate on the basis of race, color, national origin, ancestry, religion, sex, gender, age, marital status, physical or mental disability, military or veteran status, sexual orientation, gender identity, gender expression, genetic information, or any other characteristic protected by applicable federal, state or local law.

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