Staff Manufacturing 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, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE

Staff Manufacturing Engineer drives and provides support of products, processes, and equipment to achieve development and/or production goals. The engineer develops manufacturing processes to implement innovative improvements. The engineer works cross-functionally to validate processes and transfer new products into manufacturing.

RESPONSIBILITIES

Support process development and validation activities across various manufacturing product lines Design, develop, test and implement manufacturing process systems to ensure robust production processes, human work factors and quality control Design, develop and propose improvements for manufacturing process, equipment and systems using knowledge of engineering principles, industry standards and working design to meet production requirements, performance, quality, and safety standards Employ six sigma tools and scientific and statistical expertise to perform root cause and correlation analysis to identify and develop corrective actions for solving product and process failures Transfer new products & processes into manufacturing, including support of R&D builds Create, update, and maintain manufacturing documentation that meets compliance requirements Partner with outsourced vendors and suppliers to support production and resolve technical issues, working closely with MPI to establish and onboard new vendors Support manufacturing engineering efforts to meet production goals including resolution of non-conformances and line issues Perform other duties, as assigned

QUALIFICATIONS

B.S. in Mechanical, Biomedical or Industrial Engineering preferred Comprehensive SolidWorks knowledge with experience creating manufacturing fixtures, tooling, and equipment models Minimum 10 years of experience in medical device industry and electro-mechanical device manufacturing preferred Experience with Lean/Six Sigma tools and proficiency with statistical methodologies preferred Demonstrated technical acumen in navigating regulated environments Excellent interpersonal, writing, and verbal communication skills Demonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality Strong judgment & decision-making ability Excellent problem-solving skills, ability to diagnose issues and provide solutions Experience with adhesives and electronics 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:

$150,000 - $170,000 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.