Description

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 Staff Systems Engineer will be responsible for leading and maintaining system architecture, requirements definition, supporting design development, systems integration, verification and validation testing across the product lifecycle for sustaining, product iteration, and next-gen product development. The Staff Systems Engineer will also lead multi-disciplinary projects, root cause issues and analyze product field performance, and develop data driven solutions to drive product improvement impacting performance and safety.

RESPONSIBILITIES:

Lead requirements definition of system, subsystem, interface requirements and supporting definition of design outputs with cross-functional teams (R&D, quality, regulatory, clinical, user experience, manufacturing, etc)
Lead data analysis on product performance and propose data driven solutions to complex system-level performance and technical issues inclusive of hardware, firmware, algorithm, signal processing, and manufacturing.
Performs investigation and root cause analysis for field and manufacturing issues.
Lead design change impact analysis and regression test plans.
Plan and lead system-level characterization testing and verification & validation testing including protocol and report documentation as well as coordination and execution of internal testing and managing external standards compliance testing as needed.
Lead multi-disciplinary projects, ensuring scope, schedule and deliverables are met.
Lead technical and design reviews to present data analysis, project tradeoff studies, drive decisions, and align cross-functional teams.
Maintaining requirements and verification and validation traceability.
Support risk management, System Hazard Analysis, and dFMEAs. Identification of risks and proposal of risk-based decisions.
Maintains up-to-date knowledge of medical devices and technologies related to the company’s products.
Provide peer review of designs and documentation. Mentor junior engineers as the team grows.

QUALIFICATIONS:

BS in Electrical, Mechanical, Biomedical, or Software Engineering. Advanced degree preferred (Electrical Engineering preferred).
10+ years of experience in product development of electro-mechanical systems with strong medical device experience.
Successful track record of defining, developing, testing, and troubleshooting electro-mechanical, firmware and software systems to serve as systems engineering subject matter expert across cross functional teams.
Demonstrated ability to independently drive projects with rigorous system-level performance analysis with strong technical judgment to guide product design and project decisions.
Outstanding communication across different stakeholders, departments, and experience levels to drive collaboration, alignment, resolve blockers, and achieve project objectives.
Experience with requirements management and traceability tools.
Proficiency in data analysis, processing, visualization, and statistical tools such as: MATLAB, Python, Excel, Minitab etc.
Strong working knowledge of relevant standards to ensure designs meet compliance (e.g. IEC 60601, ISO 10993, IEC 62304, ISO 14971)
In-depth experience with QMS, medical product development processes, and design controls.

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: $175,000 - $185,000

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.

Staff Systems Engineer

Description

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