Full-Time
Director – Quality Engineering
Confirmed live in the last 24 hours
Develops wearable cardioverter defibrillators
Data & Analytics
Hardware
Senior
San Carlos, CA, USA
Required Skills
Python
Management
Development Operations (DevOps)
Requirements
- Minimum of 10 years of quality engineering experience in the medical device industry.
- 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.
- 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.
- 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.
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.
- 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.
Element Science develops the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD), a medical device that utilizes advanced technology to detect and treat life-threatening heart rhythms, aiming to redefine treatment for sudden cardiac death. The wearable solution addresses leading causes of death and hospitalization due to heart disease, focusing on providing a new approach to managing cardiac conditions using advanced detection and treatment technologies.
Company Stage
Series C
Total Funding
$183.1M
Headquarters
San Francisco, California
Founded
2013
Growth & Insights
Headcount