Sonendo, Inc. Principal Quality Engineer in Laguna Hills, California
Sonendo, Inc. is a privately-held, pre-IPO company with a unique mission to lead the transformation of dentistry through Sound Science®. We are currently building a high-performance team with a passion for creativity and innovation that is committed to collaboration and integrity. We believe our success is based on developing disruptive technologies, and we strive to achieve excellence in our products and services by attracting energetic, entrepreneurial individuals who are committed to this vision.
The Principal Design Assurance Engineer provides Quality Engineering support and leadership to ensure the successful development of Sonendo products. As a member of the Design Assurance team, you will have primary responsibility for influencing product quality and reliability outcomes across new product development and design change projects.
Essential Duties and Responsibilities:
• Represent Quality Engineering function on product development teams.
• Mentor Quality Engineers and quality technicians.
• Apply knowledge of Design Control principles and quality engineering techniques to positively influence product development efforts, including those for Risk Management, Specification Development, Design Verification, and Design Validation.
• Work directly with product development engineering to translate user requirements into design requirements including flow down to the component level. Provide support for the identification of critical components and design features.
• Leads risk management activities throughout the product life cycle, including Hazard Analyses, Design Failure Mode and Effects Analysis (DFMEAs), Process Failure Mode and Effects Analysis (PFMEAs), and Use Failure Modes and Effects Analysis (UFMEAs).
• Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability. Provide guidance for development of manufacturing inspection/test methods to assure process quality requirements are attained.
• Ensures appropriate statistical methodology is employed during development efforts.
• Ensures test methods are appropriate and validated for use.
• Drive predictive engineering methodology incorporating reliability and capability analysis assessments in device Design and Manufacturing processes.
• Ensure development efforts are conducted in accordance with internal/external Quality System requirements.
• Ensure compliance with Quality System procedures and company policies
• Other duties as assigned or required
Education and/or Work Experience Requirements:
• A Bachelor of Science degree in engineering (or equivalent technical discipline) is required.
• Minimum (12) years relevant work experience in a regulated industry (medical device preferred)
• Highly effective negotiation and influencing skills
• Subject Matter Expert in the following Quality core competencies:
• Design Control
• Risk Management
• Test Method Validation
• Statistical Methodology
• DMAIC Methodology
• Excellent verbal communication skills, including ability to effectively communicate with internal and external customers
• Excellent technical writing skills.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Position is primarily sedentary, and employee may be required to sit for extended periods of time.
• Standing, walking and meeting activities are required frequently throughout the workday.
• Must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.).
• Normal sight or corrected vision is required to read documents and use standard computer terminals. Some light lifting may be occasionally required.
• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
• Must be able to lift and carry up to 50 lbs
• Must be able to talk, listen and speak clearly on telephone
Sonendo offers a competitive benefits package and a collaborative, motivating work environment where you will be encouraged to innovate continuously; This is a place where you will be encouraged to actively participate, and your ideas can have a direct impact on the success of the organization. If you are interested in applying for this position, please apply online.
No recruiters, please.
Sonendo, Inc. is an Equal Opportunity Employer
Street: 26061 Merit Circle, Suite 102