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Senior Software Quality Engineer

Location: Carlsbad
Posted on: September 24, 2022

Job Description:

*POSITION SUMMARY*Canary Medical is looking for a Sr. Software Quality Engineer to assist with ensuring compliance of design control requirements and maintenance of validated state of software in and of the closed Canary Medical HIPAA/GDPR compliant Cloud and associated application (Windows, Mac, IOS, and Android) components of the Canary Health Internal Reporting Processor (CHIRP) system. This Senior Software Quality Engineer will work closely with software development team on ensuring delivery of high-quality software products and will also work closely with other compliance activities on company software validation.*SCOPE AND RESPONSIBILITIES** Together with the cross-functional team members, create, review and execute validation protocols, generate validation reports for software as part of Canary Medical devices and software.* Create and/or review functional requirements/risk assessment for software and ensure their maintenance in validated state* Support the software development teams in the creation and review of software design history files (software development plan, software verification and validation plan, production requirements document, software requirements specification, software architectural and design specification, software risk management file, test protocols and reports, and traceability matrices)* Ensure document deliveries conforming to internal SOPs and external standards and best practices* Support to ensure Canary Medical's software development compliance to FDA 21 CFR 820.30 (design control), IEC 62304 (software development life cycle), ISO 14971 (risk management), and IEC 62366 (useability engineering)* Support improvement in software quality through software quality assurance metrics and analytical tools* Additional duties assigned*Required Knowledge, Skills and Abilities: ** Understanding of software quality principles and practices in a regulated industry* Knowledge of FDA guidance for medical device software validation* Understanding or ISO 13485 principles* Strong background utilizing Microsoft Office, including Microsoft Word, Excel, PowerPoint, to perform critical job functions, trending, and reporting metrics* Strong communication, facilitation, planning, and problem-solving skills* Strong influencing and negotiation skills* Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands*Preferred Knowledge, Skills and Abilities: ** Working knowledge of software development tools - code repository, version control, compiler, builder, IDE, continuous integration, static and dynamic code analysis tools, etc.* Knowledge of AAMI TIR36*Education and Experience Requirements: ** Bachelor's degree in Computer Science, Computer Engineering, or Software Engineering or equivalent* 5+ years of experience in software development or system administration, software quality assurance, and computer system validation in a regulated industry*Department*: Quality Assurance*Reports to: * Manager, Quality Assurance*Work Location: * Remote (temporary); on-site in Carlsbad, CA once office reopens (date TBD)*Employment Type: *Exempt: accordingly, you are expected to work all hours necessary to complete the job responsibilities set forth above.*Salary: *salary commensurate with experience and* *highly competitive within industry.*Benefits: ** Unlimited PTO* Paid holidays* 401k plan* Medical, dental and voluntary vision insurance* FSA Plan*COMPANY BACKGROUND*:*Canary Medical*Canary Medical is a medical technology company focused on commercializing smart implants in the orthopedic, cardiovascular, and aesthetics markets. The company has established a considerable intellectual property portfolio surrounding its CHIRP (Canary Health Internal Reporting Processor) technology to facilitate development of active implanted devices capable of monitoring patient function utilizing MEMs sensor technology in concert with sophisticated power management algorithms and wireless data transmission.The Canary ecosystem is comprised of an implantable smart device, a base station to transmit data from the device to a secure cloud structure, and a HIPAA-compliant cloud software system to store the information, convert the raw data to useful metrics, present said data on Patient and Clinician user interfaces, and mine data for clinical insights. The Summatix platform is adjunctive and seamlessly integrated with the Canary cloud enabling Clinicians to harness CMS RPM CPT codes in the delivery of patient care.Canary both develops its own FDA approved products and partners with major and minor manufacturers to incorporate its smart CHIRP devices into their partner's FDA approved devices, allowing transmission of information _without_ clinical interpretation or medical intervention. This minimizes the regulatory burden on the medical device partner, as clinically interpreted data fall under the usual FDA regulatory pathways.The company has a robust product pipeline in several therapeutic areas and is targeting a smart Total Knee Arthroplasty (TKA) implant as its first commercial US product within the next months, followed in quick succession by other total joint arthroplasty products (hip, shoulder) owing to the fact that approximately 90% of their core technology is shared across these areas. Canary's cardiovascular efforts are targeting aneurysm, heart valves, and coronary stents monitoring. This aspect of the Canary product pipeline is earlier in development but is likewise expected to leverage core technologies from the orthopedic pipeline to reduce time to market, project costs, and regulatory risk.*Disclaimer: *Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. This description generally reflects management's assignment of essential functions but is not intended to be a comprehensive list of the duties and responsibilities of the position, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. The duties, responsibilities and job description of this role are subject to change at any time without notice._Canary Medical is proud to be an equal opportunity and affirmative action employer. We make employment decisions without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability status, pregnancy, or any other basis protected by federal, state or local law. We also consider qualified applicants regardless or criminal histories, consistent with legal requirements._Job Type: Full-time

Keywords: CANARY MEDICAL USA LLC, San Diego , Senior Software Quality Engineer, IT / Software / Systems , Carlsbad, California

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