Director, Quality Engineering

DIRECTOR, QUALITY 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:

We are seeking a Director of Quality Engineering to join our growing medical device company. This individual will be responsible for managing and leading the Quality Engineering and Software Quality Engineering teams at Element Science to meet business expectations. The ideal candidate will have excellent people skills and a can-do attitude as well as commercialization experience from medical device industries.

As the Director of Quality Engineering, you will play a pivotal role in ensuring the quality and regulatory compliance of our wearable defibrillator as we transition into the commercial phase. This is a unique opportunity to contribute to a company that is redefining the landscape of medical device technology.

RESPONSIBILITIES:

• Lead and drive the Quality Engineering and Software Quality engineering departments.
• Collaborate closely with R&D, Operations, People Operations, Clinical, and other Quality peers to ensure seamless integration of quality standards into commercial operations.
• Must be a key player in the Quality team, contributing to the overall success of the commercialization process and product pipeline.
• Drive efficiency in processes while maintaining compliance with medical device regulations and standards.
• Ownership and manage the new product development processes, aligning with FDA Design Control and ISO 14971 Risk Management standards.
• Drive and set reliability targets, testing, and validation activities align with company objectives and/or project schedules.
• Collaborate with cross-functional teams to identify and address any design issues early in the product life cycle, ensuring compliance with regulatory requirements.
• Foster collaborative relationships with R&D, Operations, HR, Clinical, and other relevant departments.
• Provide technical leadership, guidance, individual career planning, and coaching to the Quality Engineering and Software Quality Engineering teams.
• Assist with various projects as assigned.

QUALIFICATIONS:

• Minimum of 10 years of quality engineering experience in the medical device industry.
• Provides leadership on both hardware, electrical, software and system level testing.
• Proven track record with at least 8+ years in managerial roles, demonstrating effective leadership.
• Bachelor's degree in related field; master's degree a plus.
• Extensive experience in medical device development and commercialization in a start-up environment to successful product launches.
• Strong working knowledge of CFRs, EU MDRs, SaMD and IEC.
• Must have ability to review, approve and critique V&V protocols and reports of complex medical devices or circuitry.
• Knowledgeable in Python or other scripting language is desirable.
• Experience in automation frameworks.
• Must have software validation, regression testing experience and Software risk assessment.
• Experience in validating CRMs, ERP, eQMS or cloud based platforms.
• Expertise in design control, reliability testing, and quality tools.
• Extensive experience with risk management and FMEAs including FMECAs.
• Strong interpersonal and communication skills for effective collaboration.
• Experience with setting up a reliability program.
• Experience and working knowledge of relevant compliance standards and associated product testing.
• Demonstrated management skills, including leadership, talent assessment, recruitment, employee retention and development.

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