Senior Sustaining Engineer - Element Science

SENIOR SUSTAINING 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:

As we prepare to go commercial, we are seeking a talented and dynamic Senior Sustaining Engineer to join our Manufacturing team. The Senior Sustaining Engineer has a crucial role in maintaining and enhancing the performance, reliability, and functionality of products Element Science manufactures. The Senior Sustaining Engineer’s primary responsibilities will include investigating and resolving issues reported by manufacturing & operations personnel, implementing product updates, and collaborating with cross-functional teams to ensure continuous improvement.

In your initial year, you will immerse yourself in our revolutionary product, establishing yourself as a subject matter expert for addressing issues with our monitoring and defibrillating system. Additionally, you will play a pivotal role in supporting test engineering by acting as the liaison for manufacturing for the delivery of automated test system.

RESPONSIBILITIES:

• Employ solid troubleshooting, six sigma tools, scientific and statistical expertise to perform root cause and correlation analysis to identify and develop corrective actions for solving product and process failures.
• Investigate product and process issues throughout lifecycle, create reports, and implement solutions.
• Generate and analyze data to ensure performance and reliability metrics meet manufacturing goals.
• Collaborate with cross functional group to review requirements, specifications while understanding product and process risk.
• Perform verification and validation activities necessary to ensure processes are robust and meet product and quality system requirements.
• Develop and execute improvement plans to ensure the ongoing quality and reliability of products.
• Monitor and assess the performance of manufacturing processes, addressing any emerging issues promptly.
• Collaborate with product development teams to implement enhancements and improvements to existing products.
• Participate in the design, development, qualification & implementation of process and product updates, patches, and enhancements.
• Ensure that all changes meet quality standards and do not introduce new issues.
• Interface with suppliers and key vendors on technical issues including providing direction on OEM development as required.
• Undertake additional responsibilities as required to contribute to the overall success of the team and organization.

QUALIFICATIONS:

• B.S. in Electrical, Mechanical or Biomedical Engineering required.
• Minimum 8 years of experience in a sustaining engineering role or a similar position in the medical device industry and electro-mechanical device manufacturing preferred.
• Excellent problem-solving skills, ability to diagnose issues utilizing root cause analysis, and provide robust solutions.
• Strong judgment and decision-making ability.
• Demonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality.
• Excellent interpersonal, written, and verbal communication skills.
• Experience with adhesives and electronics preferred and background with medical device disposables and capital equipment, a plus.
• Knowledge of Quality Management Systems, FDA regulations, and ISO standards.
• Self-starter and an inclusive team player with the ability to work effectively in cross-functional teams.
• Commercial experience, ideally in rapid-growth manufacturing organization.

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: $138,000 - $153,000 + Annual Bonus