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Principal Software Quality Engineer

Company: Acutus Medical, Inc.
Location: Carlsbad
Posted on: May 28, 2023

Job Description:

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Principal Software Quality Engineer Professional Carlsbad, CA, US 30+ days ago Requisition ID: 1589 Acutus Medical is totally focused on the development and commercialization of solutions that improve the way complex cardiac arrhythmias are diagnosed and treated. Our passionate, driven team of innovative professionals are dedicated to providing better tools for clinicians and making life better for the millions of people who suffer from these challenging conditions around the world. Are you ready to be a part of a dynamic, innovative team with a shared purpose that truly matters? If so, we are currently looking for a Principal Engineer - Software Quality -to join us in our important mission. Position Overview The Principal Engineer - Software Quality supports Quality Assurance, R&D, and Manufacturing Engineering, and Operations in the design and manufacture of electronic medical equipment, in compliance with applicable regulatory and statutory requirements, including but not limited to 21 CFR 820 (Quality System Requirements), EN ISO 13485:2016, EN ISO 14971:2019, EN 62304:2015, and CGMP. The Engineer also assists with design controls, design transfer, and design change of software related to electronic medical products and works with engineers from R&D and manufacturing engineering to plan, perform, and test the R&D prototypes and processes into pilot production at the Acutus facility. While the position requires hands-on work, it is expected that the incumbent is consistently imbedded in a cross-functional, product-centric team. This role ensures that the contents of Software Design History Files, Device Master Records, and Device History Records are accurately developed, that the Software designs are properly verified and validated, in accordance with the Company requirements, regulatory requirements, and FDA guidelines, also this Engineer will be in-charge of provide failure analysis investigation for software complaints. Duties and Responsibilities

  • Performs and/or reviews product software acceptance testing; reviews and approves test results; creates, reviews, and approves test data and test reports.
  • Represents Software Quality Assurance during the Design Control and Design Review process through review and approval of the applicable Design Input, Design Output, Design Verification, Validation, and Design Transfer.
  • Assists with the definition and deployment of downstream processes, such as field service procedures, issue investigation, and investigation of product returns.
  • Supports all company internal and external audit functions and coordinate activities of third party audits.
  • Supports activities related to Management Review, CAPA, Nonconforming materials, Process Deviations, Complaints, Product Field Actions, internal and external audits, and related document control functions.
  • Performs and/or reviews of Software product acceptance testing, and test results.
  • Perform In-process and Field Complaints Investigations and Reports
  • Perform Software failure trending analysis.
  • Perform Software Test analysis from Software test issues database.
  • Participates in onsite Software Testing.
  • Supports Software cybersecurity risk analysis testing, Software threat modeling plans, & Software penetration testing. -
  • Supports Software Quality Test Automatization -
  • Builds consensus and gains support of key stakeholders. Contributions greatly impact the overall team's objectives. Coordinates across and within the organization to determine appropriate resources and budget to complete projects in the most-efficient manner. Helps influence decisions within the department and for projects to avoid shortcomings. Encourages a cohesiveness team by being an exemplary team player. Maintains a high degree of quality in all work performed and overseen. Demonstrates group-wide influence and technical competence, particularly in the languages and techniques used in Acutus engineering.
  • Exercises independent judgment in creating and innovating methods, techniques and evaluation criteria for obtaining results. Demonstrates ability to discover and identify processes, novel science and technology, which leads to increased productivity and results. Leads others while being equitable and respectful to others. May be responsible for direct reports. People management responsibilities may include hiring / terminations, performance reviews, career development coaching and compensation decisions.
  • Is responsible for compliance with quality system procedures and all regulatory requirements. Qualifications
    • Typically requires a minimum of 10 years of related experience and a Bachelor's and/or Master's degree, and/or PhD in a scientific/engineering discipline; or equivalent combination of education and experience.
    • Experience in complex electronic medical devices working within Quality is required.
    • Applied understanding of 21 CFR 820, EN ISO 13485:2016, ISO 14971:2019, and EN 62304:2015.
    • Demonstrated experience in Software Design Controls and Risk Analysis.
    • Demonstrated expertise in Software Verification and Validation.
    • Demonstrates technical expertise and implementing innovative solutions. Regularly collaborates with others and provides independent thought in suggesting and influencing design and research strategies. Works on complex problems in which analysis of situations or data requires an in depth evaluation and may impact future concepts and technology. May be required to actively contribute to regulatory filings, patent applications and other industry related publications. Demonstrates high level of strategic and global thinking.
    • Capable of working thoughtfully under pressure and in a timely manner. Founded in 2011, Acutus Medical is headquartered in Carlsbad, CA. We pride ourselves on being an innovative company comprised of dedicated and talented industry leaders working together to make a distinctive mark within the Electrophysiology market. Our team works diligently to fulfill the mission of bringing advanced tools for physicians and hospitals to access, identify, diagnose and treat complex arrhythmias to in order to optimize and expand the success of cardiac ablation. The anticipated salary range for candidates is $130,000 to $160,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Our employees enjoy working in a company that truly cares about them, their career and overall wellbeing. We offer competitive salaries, comprehensive benefits, paid time off, holidays and a variety of health and wellness programs. We are steadily growing and look forward to adding more talent to our team. Acutus Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Acutus uses E-Verify for all employment verifications. We are not accepting resumes from 3rd party headhunters or agencies .

Keywords: Acutus Medical, Inc., San Diego , Principal Software Quality Engineer, IT / Software / Systems , Carlsbad, California

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