Director, Sustaining Engineering

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:

The Director, Sustaining Engineering leads all facets of sustaining engineering activities at Element Science. The role is accountable and will oversee all aspects of product lifecycle management, including design changes, quality improvements, regulatory compliance, and cost optimization of commercial products. Additionally, the position is responsible for planning, organizing, and managing a trained, disciplined and motivated work force capable of meeting changing production needs in a dynamic business environment.

RESPONSIBILITIES:

• Develop and implement strategic plans for sustaining engineering activities, aligning with company's objectives and regulatory requirements.

• Recruit, hire, train, guide and deliver career development for sustaining engineering staff.

• Primary lead contact for other functions such as PMO, Sales, Finance, QA, R&D, Manufacturing to drive product improvements and resolve technical issues. Collaborate and communicate effectively with stakeholders to ensure alignment and transparency to achieve company objectives.

• Oversee all aspects of commercial product lifecycle, including design changes, product enhancements, and component obsolescence management. Ensure that products meet or exceed quality, performance, and regulatory standards throughout their lifecycle.

• Identify and mitigate risks associated with product changes, quality issues, and regulatory compliance. Implement risk management processes and tools to assess and mitigate risks throughout the product lifecycle.

• Drive initiatives to improve manufacturing efficiency, reduce scrap and rework, and optimize supply chain processes. Continuously monitor production costs/yields and standards to ensure that products are manufactured at the lowest costs while maintaining product quality and compliance.

• Develop and implement Sustaining Engineering annual operating and capital budgets to meet long-term company and department objectives.

• Lead assessments on the selection of suitable capital equipment and systems for optimal balanced line performance. Make final recommendations to management.

• Promote a culture of continuous improvement within the sustaining engineering team and across the organization. Implement best practices, tools, and methodologies to enhance productivity, quality, and innovation.

• Support the company's Quality Policy and Quality System and participate in maintenance, continuous improvement, and periodic review of the Quality System, including plans and metrics, and their integration into the strategic and annual business plans.

• Ensure that manufacturing is in compliance with FDA, GMP, ISO 13485, ISO 14971 and MDD requirements.

• Perform other duties as assigned.

QUALIFICATIONS:

• Bachelor's in a mechanical, electrical, biomedical or equivalent engineering discipline (advanced degree preferred)

• Minimum 10+ years of engineering related experience and/or training, preferably with Class II or Class III medical devices. Minimum 7+ years of management experience.

• Ability to work in an early commercializing company with a stressful environment, managing challenges and build consensus.

• Eagerness to accept personal accountability while functioning as part of a management team which defines success as timely achievement of goals.

• Strategic thinker, with the imagination and foresight to conceptualize new ideas and opportunities as well as the implementation skills to bring them into fruition.

• Flexibility and self-reliance. Hands on experience developing, implementing, and upgrading production systems and controls. Excellent analytical, planning, and communication skills

• People-oriented, intelligent, professionally aggressive, with a strong work ethic and stamina

• Thorough understanding of FDA Medical Device GMP, ISO 13485, ISO 14971 and European MDD requirements. Demonstrated ability to optimize product design for purpose and manufacture and continuously improve production processes within a lean resource start-up environment.

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: $215,000 - $228,000 + 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.