Lead Software Quality Assurance Specialist

2 weeks ago

Redwood City, California, United States Element Science Inc Full time

LEAD SOFTWARE QUALITY ASSURANCE SPECIALIST

ABOUT THE ORGANIZATION:

Element Science, Inc. is at the forefront of medical technology and digital health innovation, dedicated to creating solutions that merge clinical-grade wearable devices, advanced machine learning, and critical therapies. Our mission is to tackle the leading causes of mortality and hospitalizations in heart disease patients, particularly during their transition from hospital to home care. By prioritizing the needs of both patients and healthcare providers, our user-friendly digital devices aim to transform the care paradigm for these individuals. Our flagship product, a wearable patch defibrillator, is designed to assist over 500,000 patients in the United States who face a temporary elevated risk of life-threatening heart rhythms. Our headquarters are located in San Francisco, and we are supported by prominent investors including Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

ROLE OVERVIEW:

In the capacity of Lead Software Quality Assurance Specialist, you will collaborate closely with the software development team to uphold the highest standards of Quality Assurance and Engineering throughout the software development lifecycle. You will ensure that all corporate business requirements, regulatory standards, and other relevant criteria are consistently met. This position is hands-on, requiring you to leverage your extensive knowledge of engineering and quality principles to enhance Element Science's software and platforms.

KEY RESPONSIBILITIES:

  • Develop validation plans, protocols, and software risk assessments for medical devices.
  • Conduct validation testing in accordance with product specifications.
  • Draft, review, and approve documentation for verification and validation (V&V) software testing and test scripts.
  • Work collaboratively with firmware and software research and development engineers to drive improvements and innovations.
  • Provide expert guidance on Threat Modeling for cybersecurity initiatives.
  • Mentor and coach junior team members on industry best practices.
  • Lead and contribute to project teams focused on new product development.
  • Assist in addressing and investigating customer complaints related to software products.
  • Engage in monitoring and analyzing software anomalies.

REQUIRED QUALIFICATIONS:

  • Bachelor's degree in Software Engineering, Electrical Engineering, or Computer Science.
  • A minimum of 7 years of relevant experience in the medical device sector.
  • Proven experience in drafting and executing validation and verification plans, protocols, and software risk assessments for medical devices.
  • Experience with embedded software in medical devices.
  • Exceptional cross-functional communication skills.
  • Strong written communication skills for documenting V&V outputs.
  • Familiarity with C or other scripting languages is a plus.
  • Experience with automation frameworks.
  • Knowledge of Threat Modeling and Software Risk Management.
  • Understanding of FDA regulations, Software Validation Guidance, 21 CFR part 820, IEC 62304, and IEC standards.

COMPENSATION AND BENEFITS:

Element Science offers a competitive salary and comprehensive benefits package, which includes:

  • Stock Options
  • 90% employer-covered medical, dental, and vision insurance
  • Company-funded Basic Life Insurance
  • 401(k) retirement plan options (Traditional and Roth)
  • Generous Paid Time Off
  • Paid Holidays
  • Flexible Spending Accounts (FSA)
  • Health Savings Account (HSA)
  • Employee Assistance Program through PEO

The salary for this exempt position will be determined based on experience and qualifications within a defined pay range.

  • Salary range: $140,000 - $150,000 + Annual Bonus

Element Science is an Equal Opportunity Employer. All candidates will be assessed based on their qualifications for the role. Employment decisions are made without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by law.

In compliance with federal law, all hires will be required to verify their identity and eligibility to work in the United States and complete the necessary employment eligibility verification form upon hire. We are unable to sponsor individuals for employment visas for this position.

Currently, we are unable to provide relocation assistance at Element Science.

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