Senior Software Quality Assurance Engineer

Job Description

Job Description

Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients. Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm. Headquartered in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

We're seeking a Senior Software Quality Engineer who brings both technical excellence and a deep sense of purpose to their work. This role plays a critical part in ensuring the integrity, safety, and reliability of our medical devices through rigorous software quality practices. As a key member of our Software Quality team, you will collaborate closely with software engineering and cross-functional partners to uphold the highest standards of quality and regulatory compliance.You will lead initiatives to create, review, and maintain clear, audit-ready documentation; develop and enhance automated testing frameworks; and oversee manual testing processes throughout the software development lifecycle. Your expertise in software documentation, verification, and automation will help ensure that every line of code meets our uncompromising commitment to patient safety, product performance, and regulatory excellence.

RESPONSIBILITIES:

• Author validation plans, protocols, software risk analyses for a medical device.
• Execute validation testing based on product requirements.
• Create, review and approve reports for V&V software testing and test scripts.
• Collaborate with firmware and software R&D engineers on improvements or new products.
• Coach and mentor junior team members on current best practices.
• Lead and participate in project teams assigned to new products.
• Support and investigate customers' complaints related to product software.
• Involved in monitoring software anomalies.

QUALIFICATIONS:

• Bachelor's degree in Computer Science, Software Engineering, or related field, or equivalent experience.
• A minimum of 7+ years of recent medical device experience.
• Experience writing and executing validation/verification plans, protocols, and software risk analysis on Medical Devices.
• Medical Device experience covering embedded software.
• Strong cross-functional communication skills.
• Strong written skills to define and document V&V outputs.
• Experience with scripting or programming (Python, C, or similar).
• Experience in automation frameworks.
• Experience in Threat Modeling and Software Risks.
• Working knowledge of FDA, Software Validation Guidance, 21 CFR part 820, IEC 62304, and IEC 82304-1.
• Knowledge of software quality and regulatory compliance (ISO 13485, IEC 62304) is a plus.
• Excellent written and verbal communication skills.

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:

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

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $140,000 - $150,000 + Bonus

Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's 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 local, state, or federal law.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job.

At this time, we are unable to offer relocation assistance at Element Science.