Associate R&D Engineer - Long Beach, CA at Hydrafacial · Long Beach

Summary: Hydrafacial is a global category-creating company focused on bringing innovative products to market and delivering beauty health experiences. The R&D Engineer will support the research and development engineering of innovative medical aesthetic devices, collaborating with various teams to bring next-generation technologies to market. Responsibilities: - Support the design and development of electro-mechanical assemblies for new and sustaining aesthetic device platforms - Assist in the creation and maintenance of design control documentation in accordance with FDA 21 CFR 820.30, including Design History Files (DHFs), Design Input/Output documents, Verification & Validation protocols, and reports - Contribute to the generation and review of engineering requirements, test protocols, technical reports, and risk management documentation (FMEA, hazard analysis) - Assist in the preparation and execution of design verification and validation (V&V) testing - Create and revise engineering drawings and CAD models; support tolerance stack-up and design-for-manufacturability reviews - Utilize 3D printing and rapid prototyping tools to support concept development and design iterations - Collaborate with cross-functional teams to support Change Orders (COs), Engineering Change Requests (ECRs), and deviations - Support sustaining engineering activities including failure investigations, root cause analysis, and corrective actions (CAPAs) - Maintain organized and compliant documentation in accordance with ISO 13485 Quality Management System requirements - Other duties as assigned Required Qualifications: - B.S. degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical field - 0–3 years of experience in a product development or engineering role (internship, co-op, or full-time experience accepted) - Familiarity with electro-mechanical assembly design and integration - Basic understanding of FDA design controls (21 CFR 820.30) and/or ISO 13485 quality management systems - Proficiency or coursework experience with CAD software (SolidWorks preferred) - Strong attention to detail and ability to maintain accurate, compliant documentation - Effective written and verbal communication skills with the ability to work in a collaborative, cross-functional environment Preferred Qualifications: - Experience with or exposure to FDA-regulated medical device development - Knowledge of aesthetic or consumer wellness devices - Hands-on experience with 3D printing / rapid prototyping technologies - Familiarity with ISO 13485 QMS implementation - Understanding of GD&T and engineering drawing standards - Experience with design verification/validation (V&V) testing Required Skills: Electro-mechanical assembly design, FDA design controls (21 CFR 820.30), ISO 13485 Quality Management System, CAD software (SolidWorks), Design History Files (DHF) documentation, Design Input/Output documentation, Verification, Validation (V&V) testing, Risk management documentation FMEA, Risk management documentation hazard analysis, Engineering drawing, GD&T standards, 3D printing, rapid prototyping, Root cause analysis, Corrective, Preventive Actions (CAPAs), Effective written Benefits: Medical insurance, Dental insurance, Vision insurance, FSAs, HSAs, Accident insurance, Pet insurance, Company-paid life and AD&D insurance, Company-paid long-term and short-term disability insurance, 401(k) with employer match, Paid time off (PTO), Paid holidays