Senior Systems Engineer

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. Based in San Francisco and Redwood City, California, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

The Senior Systems Engineer will be responsible for performing systems engineering functions across all stages of product development including system architecting, requirements definition, concept generation, prototyping, design, verification and validation testing and reporting, tracing, design documentation, troubleshooting, and production support.

This position is a hybrid role based in our San Francisco, CA office.

RESPONSIBILITIES:

• Define system, subsystem, and interface requirements for products based on cross functional input; clinical, marketing, user experience groups etc.

• Execute design trade off analyses balancing patient and business needs with technical complexity and schedule risk.

• Perform root-cause device investigations (related to both manufacturing and product use), gathering input from quality and engineering subject matter experts.

• Drive system-level characterization testing and design verification & validation testing, including coordination and execution of internal testing and managing external test houses.

• Create and visualize data extracted from the system to understand product performance and propose product improvements.

• Maintain up-to-date knowledge of national and international standards related to the design of Element Science products.

• Maintain up-to-date knowledge of medical devices, technologies, and regulatory landscape related to the company's products.

• Work cross-functionally with engineering, quality, manufacturing, and regulatory groups to achieve alignment on design strategies, testing strategies, release of design documentation, root cause analysis etc.

QUALIFICATIONS:

• Bachelor's in Biomedical, Computer, Electrical or Mechanical Engineering, Advanced degree preferred.

• 5-12 years of experience in product development of electro-mechanical systems with a significant portion being medical device experience.

• Experience capturing architectures and product requirements writing / interpretation.

• Experience with hazard analysis and risk management processes.

• Knowledge of relevant standards and regulations for medical devices such as ISO 13485, IEC 60601, and FDA guidelines.

• Coding experience in at least one of the following languages MATLAB, Python, R, C++ is a plus.

• Experience with statistical analysis and/or DOE using MATLAB, Minitab, Excel or similar is a plus.

• Outstanding communication skills, including the ability to moderate engineering discussions and work as a bridge among different engineering departments and stakeholders.

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: $155,000 - $166,000 + Annual Bonus + Stock Options

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.