Senior Quality Engineer

The posting, as Element Science wrote it

Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery.

We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE

Element Science is seeking a Sr. Quality Engineer to support the ongoing quality, reliability, and continuous improvement of our life-saving medical device technology. This role provides Quality Engineering support across the commercial product life cycle and leads the supplier quality program. It partners closely with Engineering, Manufacturing, Supplier Quality, Operations, Supply Chain and other cross-functional teams to ensure products and purchased components continue to meet quality, safety, performance, and regulatory requirements throughout the commercial product lifecycle.

The Sr. Quality Engineer will provide Quality Engineering support for product and process changes, nonconformances, CAPAs, complaints, supplier qualification and performance, risk management, and verification and validation activities. This role will partner with manufacturing on process capability and provide Quality oversight and approval to those activities.The ideal candidate brings strong technical problem-solving skills, sound quality judgment, and a collaborative, hands-on approach to identifying root causes and driving sustainable improvements.

RESPONSIBILITIES

Sustaining Quality

• Serve as the Quality Engineering partner for sustaining engineering and post-market product activities, ensuring continued compliance with applicable quality and regulatory requirements.
• Provide Quality oversight for product, component, manufacturing, supplier, and design changes, including assessment of verification and validation requirements.
• Support nonconformance, complaint investigation and CAPA activities, including root cause analysis, risk assessment, corrective actions, and effectiveness verific

[…]
ommercial product lifecycle.

• Strong technical problem-solving and root cause analysis skills.
• Bachelor’s degree in Engineering, Science, or a related technical discipline; Master’s degree is a plus.
• Ability to work effectively across Engineering, Manufacturing, Operations, Supplier Quality, and other cross-functional teams.
• Strong organizational skills with the ability to manage multiple priorities and consistently complete work on schedule.
• 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: $104,000 - $132,000

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.