Staff Manufacturing Engineer

Element Science • Redwood City, CA

4h

About The Position

Element Science, Inc. is a medical device and digital health company focused on redefining how patients with heart disease are monitored and treated during their transition from hospital to home. The company's mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions combining clinical-grade wearables, advanced algorithms, and therapy delivery. Element Science is currently in an exciting phase of growth, moving from development into early commercialization. Their product is a wearable patch defibrillator designed for patients with a temporary elevated risk of sudden cardiac arrest, targeting over 500,000 patients in the U.S. The company emphasizes comfort, usability, and clinical effectiveness to transform the standard of care. Headquartered in the San Francisco Bay Area, Element Science is supported by leading healthcare and technology investors. The Staff Manufacturing Engineer will drive and support products, processes, and equipment to achieve development and production goals. This role involves developing manufacturing processes for innovative improvements and working cross-functionally to validate processes and transfer new products into manufacturing.

Requirements

• Comprehensive SolidWorks knowledge with experience creating manufacturing fixtures, tooling, and equipment models
• 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
• Strong technical expertise with manufacturing processes, automation, and materials

Nice To Haves

• B.S. in Mechanical, Biomedical or Industrial Engineering
• Minimum 10 years of experience in medical device industry and electro-mechanical device manufacturing
• Experience with Lean/Six Sigma tools and proficiency with statistical methodologies
• Experience with adhesives and electronics
• Background with medical device disposables and capital equipment a plus

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 11-50 employees