Principal Electrical Engineer

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:

The Principal Electrical Engineer is the senior technical subject matter expert for the electrical design and manufacturing integrity of our commercially released Class III products. This role keeps marketed devices safe, reliable, compliant and cost-effective throughout their lifecycle by resolving production issues, leading test strategy efforts, managing component obsolescence, and driving continuous improvement at both internal and external manufacturing sites. The Principal works across Manufacturing, Quality, Regulatory Affairs, R&D, Supply Chain, and Commercial Operations.

RESPONSIBILITIES:

• Design, develop, and implement manufacturing processes, equipment, and systems using knowledge of engineering principles, industry standards, and working design to ensure robust production processes, human work factors, quality, and safety standards.
• Lead test strategy and development of manufacturing test systems for released electrical assemblies (PCBAs, sub-assemblies, and finished devices), including test coverage, fixtures, automated test stations, and test software, driving test method validation and transfer to internal and external manufacturing sites to ensure robust defect detection, yield, and compliance
• Lead root cause and correlation analysis on test failures and non-conformances to identify and develop corrective actions for solving product and process failures using six sigma tools and scientific and statistical expertise.
• Serve as lead subject matter expert to interface with external suppliers and manufacturers on technical issues such as component end of life, yield issues, test development, and supplier change impact assessments.
• Deliver work that complies with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601-1 and applicable collateral and particular standards (including IEC 60601-2-4), and IPC Class 3 workmanship standards.
• Lead cross-functional project teams and communicate technical status, risks and recommendations to senior leadership while mentoring and providing technical guidance to engineers across departments.
• Support internal and external audits and inspections (FDA, notified bodies, customers) as a technical representative.
• Support R&D Engineering to transfer new products & processes into manufacturing
• Accommodate periodic international travel to Asia (Thailand, Malaysia)
• Perform other duties, as assigned

QUALIFICATIONS:

• B.S. in Electrical Engineering, Electronics Engineering, or a related field required
• Comprehensive Altium experience creating and modifying electrical design elements
• 10+ years of electrical engineering experience, with at least 5 years in a regulated medical device environment; substantial experience supporting released products in a manufacturing setting
• Experience with Lean/Six Sigma tools and proficiency with statistical methodologies preferred
• Excellent interpersonal, writing, and verbal communication skills
• Demonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality
• Strong decision-making ability and problem-solving skills within a collaborative setting
• Experience with adhesives preferred and background with medical device disposables and capital equipment a plus
• Strong technical expertise with manufacturing processes, automation, and materials

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: $180,000 - $200,000

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.