Principal Software Quality Engineer
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Job Location:
Mountain View, CA - USA
Monthly Salary:
$ 124 - 165
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Based in Mountain View CA. NeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differential RNS System is the first and only commercially available brain-responsive platform that delivers personalized real-time treatment at the seizure source.
At NeuroPace employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace our success depends upon our ability to recruit and retain the most talented enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive.
We are currently seeking a Principal SoftwareQualityEngineerto join our team. This willbe an individualcontributorroleworkingcollaboratively withthe Quality Design Assurance Engineering teamProduct DevelopmentProduct MonitoringITandClinical Research teamson productdesigndevelopment through the product development lifecycle
Key Responsibilities
- Participateinproject teams and provide guidance to the team on software quality related activities (product software and firmware) assuring adherence to the software development lifecyclewhich may include PCCP strategy development. Assure that design controls are met; project plans include relevant software deliverables andobjective measurable and verifiable customer and product requirements establishmentand adherenceofproject schedules.
- Update processes implement templates and mentor users in ensuring compliance withFDA QSR Part 820ISO 13485ISO62304and ISO 62366.
- Ensure compliance with software risk standards byparticipatingin risk management activities and ensuring compliancewithrisk management documentation such as software risk analyses safety analyses communication analysessFMEA.
- Ensure compliance with cybersecurity procedures and standards. Ensure that software risk analyses include cybersecurity risks and define processes for threat modeling.Assistin the writing of cybersecurity risk management reports.
- Assess algorithmic design and implementation for robustness bias and adherence to regulatory requirements. Ensure proper validation and verification of AI-driven features including transparency and explainability of models.
- Ensure compliance with SaMD regulatory landscape.
- Assure that software architecture is properlyestablishedand challenge software architectures/designs and requirements for adequacy safety and robustness.
- Review software verification plansprotocolsand reports for compliance with procedures and regulations.
- Apply usability engineering knowledge during applicableanalyses andreviews.
- Represent Quality onthe Software Change Board (SCB).
- Verify and implement laptop and tablet PC replacements to support manufacturing.
- Assess data and analyticsas needed.
- Supportaudits by global regulators to support ISO 13485 MDSAP Health Canada and CE Mark audits.
Requirements
- BS degree in a recognized engineering discipline preferably Software Engineering.
- 10yearsminimum experience as a quality professional inthe medical deviceindustry.
- Demonstrated working knowledge of FDA QSR ISO 13485ISO 62304 ISO 62366MDSAP and MDR.
- Excellent verbal and written skills interpersonal skills.
- ASQ certificationsdesired but not necessary.
$124-$165K Base - Compensation will be determined based on several factors including but not limited to skill set years of experience and geographic location.
NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.
Fraud Alert: Were aware of fake job postings using NeuroPaces name. Legitimate communications only come from @ emails and never request personal financial info or other personal data upfront. Please verify suspicious messages by contacting us directly. View our current job openings: Dental & Vision Insurance
NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.
San Francisco and Los Angeles applicants: The Company will consider for employment qualified applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance in Hiring Ordinance or the San Francisco Fair Chance Ordinance (as applicable)
PRIVACY NOTICE: NeuroPace takes its responsibility to protect your personal information seriously and it uses reasonable safeguards to avoid unauthorized use or disclosure of it and inadvertent loss or impermissible alteration of it. NeuroPace complies with all applicable federal and state laws and regulations that govern the handling of your personal information. If you would like more detailed information on NeuroPaces privacy policies please refer to for reference. NeuroPace retains candidate resumes and applications in its files for future reference and/or consideration for other available job postings. If you do not wish for your resume and applications materials to be retained in NeuroPace files or wish to obtain a listing of any personal information that NeuroPace has stored about you please contact us at .
Key Skills
- Continuous Integration
- Docker
- Jenkins
- Python
- System Design
- Agile
- C/C++
- Go
- Systems Engineering
- Software Development
- Java
- Distributed Systems
About Company
The NeuroPace RNS System is the only FDA-approved epilepsy device that delivers personalized treatment by responding to abnormal brain activity and provides EEG data that can help improve patient care.
