Principal Manufacturing Engineer

PRINCIPAL MANUFACTURING ENGINEER

THE COMPANY: 

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, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

Principal Manufacturing Engineer leads team to drive and provide support of products, processes, materials, and equipment in order to achieve 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:

• Lead process development and validation activities.
• Design, develop, test and implement manufacturing processes systems in manufacturing including production processes, human work factors, quality control, inventory control, logistics and material flow, cost analysis, and production 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 into manufacturing, including support of R&D builds.
• Create, update, and maintain manufacturing documentation that meets compliance requirements.
• Interface with suppliers and key vendors on technical issues.
• Leads manufacturing engineering efforts to meet production goals including resolution of non-conformances and line issues.
• Perform other duties, as needed.

QUALIFICATIONS:

• Bachelor's degree in Mechanical, Biomedical or Industrial Engineering preferred.
• Minimum 13 years of experience in medical device industry and electro-mechanical device manufacturing preferred.
• Experience with Lean/Six Sigma tools and proficiency with statistical methodologies acquired through formal training and/or direct work experience.
• 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.
• Must have excellent problem-solving skills, ability to diagnose issues, and provide solutions.
• Experience with disposables and capital equipment a plus.

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 - $195,000 + Annual Bonus