Software Design QA Engineer

 Location: Larkspur, CA

Travel: Akili currently has two office locations, Boston and San Francisco.  In order to support the management and workforce on both coasts, this position requires up to 25% domestic travel to Boston, MA.

Job Description:

Akili is looking for a Software Design QA Engineer who will have an important role on supporting implementation of FDA 21 CFR Part 820, IEC62304, ISO13485 and EU MDD requirements within a fast-growing Software Medical Device (SaMD) company.

Specific duties include:

  • Create and maintain Design Control deliverables (Design History Files, Device Master Records, Technical File)

  • Provide support to Product, Design & Engineering teams on developing & organizing design documentation such as user needs, software requirements specifications, risk management, software design specifications, v&v plans and results

  • Provide support organizing design reviews and following up on action items

  • Investigate Customer Complaints

  • Investigate Non-conformances

Qualifications:

  • BS degree in Computer Science or Engineering preferred

  • Minimum of 3 years’ experience

  • Experience with software quality assurance

  • Proficiency with 21 CFR Part 820, IEC62304, ISO 13485 & CE Marking requirements

  • Ability to work in an FDA-regulated industry

  • Observe and comply with quality policies, procedures and work instructions

  • Ability to handle multiple tasks simultaneously and ability to manage project timelines

Accommodations:

Reasonable accommodations will be made to enable individuals with different abilities to perform the essential functions.

Akili is an equal opportunity employer that embraces diversity and inclusion.

To apply for this position, contact us through Puretech Health.