Senior Quality Engineer

Our Mission

Happiest Baby is a mission-driven company helping parents raise healthy, happy children. We created SNOO, a smarter, safer baby bed, and are also developing many more landmark products, content, and services.

SNOO adds 1-2 hours of sleep per night and keeps babies in the safest position for sleep, the back. Back sleeping is associated with a reduced risk of SIDS (which kills 3,500 sleeping babies/year). In fact, SNOO received FDA De Novo Approval for its ability to keep sleeping babies on their back. SNOO has won more top awards than any other baby bed, helped hundreds of thousands of parents, is used in over 100 hospitals, is a top employee benefit at scores of companies, and has been exhibited in six of the world's top museums (including being invited into the permanent collection of the Smithsonian Institution!).

Happiest Baby was founded by one of the world's most trusted pediatricians, Dr. Harvey Karp, and his entrepreneur wife, Nina Montée-Karp. Dr. Karp's celebrated books/videos have helped millions of parents and are translated into over thirty languages. Released in 2016, SNOO is the result of a collaboration between Dr. Karp, award-winning industrial designer Yves Behar (founder of SF-based, Fuseproject) and Dr. Deb Roy (Director, Laboratory for Social Machines, MIT Media Lab).

Responsibilities

• Quality Assurance activities

• Support production and refurbishment with quality plans and standards, first article inspections, pre-production sample signoff, OBA, creating/maintaining work/inspection instructions, and preparation for audits (internal, enterprise, customer). Lead risk analysis activities and FMEAs, and support verification and validation activities. Ensure quality is built into processes as transferred to manufacturing and refurbishment.

• Manage and lead teams with ECOs and CAPA issuance and complaint investigations.

• Utilize statistical methods and data analysis techniques to identify trends, patterns, and root causes of quality issues, driving proactive quality improvements and risk mitigation strategies.

• Analyze and improve supplier quality metrics.

• Establish Critical-to-Quality performance metrics to measure and improve product quality.

• Drive the continuous improvement process based on Root Cause Analysis (RCA) and identified opportunities.

• Serve as an Internal Auditor to support the quality internal audit program.

• New Product Introduction activities

• Manage NPI builds and quality phase-gate deliverables throughout the product development lifecycle, from concept through production readiness.

• Participates in design reviews, design transfers, and in all aspects of the Design Control process for new products. Actively participate in and guide all aspects of Design Control and Change Control.

• Develop and establish quality plans for all products.

• Compliance activities

• Ensure that all work activity is performed in accordance with established internal procedures, and FDA's Quality System Requirements, such as 60601 and MDR.

• Support activities associated with agents of regulatory bodies as necessary to demonstrate quality system compliance.

• Support regulatory and safety certification / recertification activities for US, European and other markets.

• Mentor and provide guidance to peers and quality team members on best practices.

Background:

Minimum Requirements:

• Bachelor's or Master's degree in Engineering (or related field) with 7+ years of experience in medical or consumer-electronics products.

• Proficiency in interpreting and ensuring compliance with regulatory and safety standards and the quality management system (QMS) requirements.

• Experience in data-drive root-cause analysis, continuous improvement methods, and reading manufacturing/inspection work instructions.

• Strong understanding of engineering principles, design analysis techniques, and manufacturing processes (e.g., assembly, inspection, test).

• Ability to read mechanical drawings (including GD&T) and specifications.

• Effective communication skills and ability to prioritize tasks based on business needs.

• Proficiency in Microsoft Office Suite and collaboration tools like Microsoft Teams, OneNote, SharePoint 365.

• Willingness to travel domestically and internationally as needed.

Preferred Requirements:

• ASQ Certification as a Certified Quality Engineer (CQE) and Six Sigma Green Belt.

• Proficiency in performing Supplier Quality Systems Audits and monitoring supplier performance.

• Demonstrated leadership in cross-functional teams and strong project management skills.

• Understanding and proficiency in quality tools such as 8D, SPC, FMEA, PPAP, etc.

• Ability to analyze large data sets and make data-driven decisions.

• Knowledgeable with document control systems like Arena.

• Experience testing full IoT products, including firmware and software.

Perks

• Competitive health/dental/eyecare plan

• Take it as you need it vacation policy

• 401(k) plan

• Daily catered lunches at the office

• Working with a great team that is literally saving babies' lives

Salary range: $85,000 - $130,000