Principal Mechanical Engineer - Long , CA

The Principal Mechanical Engineer will serve as a technical leader within Skin Health System's R&D organization, driving the design and development of next-generation products and adjacent device platforms in a design‑controlled, FDA‑regulated environment.

• Act as technical lead for one or more concurrent product development projects, coordinating design constraints across the mechanical engineering team and other R&D functions.
• Provide mentorship and technical guidance to junior and mid‑level engineers; participate in hiring, onboarding, and capability development.
• Define material selection criteria and design trade‑offs across plastic, metal, and elastomeric components relevant to aesthetic and wellness device platforms.
• Lead the design and development of electromechanical assemblies, fluid systems, and precision mechanisms for new and sustaining device platforms.
• Own the creation, review, and maintenance of design control documentation per FDA 21 CFR 820.30 and ISO 13485, including Design History Files (DHFs), Design Input/Output documents, Verification and Validation protocols, and reports.
• Create part and sub‑system requirements based on design requirements and best mechanical engineering practices; ensure components meet all system‑level requirements.
• Define test methods and protocols, execute testing, and document results and conclusions for design verification and validation (V&V) activities.
• Leverage FEA tools for thermal and structural analysis to validate designs prior to physical build.
• Generate and review engineering drawings and CAD models; lead tolerance stack‑up analyses and design‑for‑manufacturability (DFM) reviews.
• Utilize 3D printing and rapid prototyping to support concept development and design iterations at speed.
• Resolve design conflicts and technical risks with limited managerial intervention; escalate appropriately when needed.
• Prepare, present, and document designs at technical design reviews with cross‑functional stakeholders and senior leadership.
• Collaborate with Quality, Regulatory, and Operations teams to support Change Orders (COs), Engineering Change Requests (ECRs), deviations, and CAPA activities.
• Maintain compliant documentation within Skin Health System's ISO 13485 Quality Management System.

• B.S. in Mechanical Engineering or equivalent technical degree, with 8+ years of progressively responsible product design and development experience; or M.S. in Mechanical Engineering with 6+ years of equivalent experience.
• Minimum 3 years of experience functioning as a technical lead or subject matter expert, managing projects with minimal managerial supervision.
• Minimum 3 years of experience performing product development in FDA‑regulated medical devices.
• Minimum 2 years working in a matrixed organization, synthesizing multiple tasks across departments and communicating about project goals, schedules, and planning in writing and orally to peers, business leaders, and senior management.
• Deep working knowledge of FDA design controls (21 CFR 820.30) and ISO 13485 quality management systems.
• Advanced proficiency in Solid Works or equivalent CAD platform, including assembly modeling and drawing creation.
• Strong understanding of GD&T, tolerance stack‑up analysis, and engineering drawing standards.
• Excellent written and verbal communication skills with demonstrated ability to lead design reviews and present to senior leadership.

• Experience with aesthetic, dermatology, or consumer wellness medical devices.
• Familiarity with fluid system design, vacuum systems, or tip/handpiece assemblies relevant to hydradermabrasion platforms.
• Hands‑on experience with 3D printing and rapid prototyping technologies.
• Experience with design for manufacturing and assembly (DFMA) in low‑to‑medium volume production environments.
• Familiarity with risk management documentation including FMEA and hazard analysis under ISO 14971.
• Experience supporting sustaining engineering, root cause analysis, and corrective action (CAPA) processes.

$160,000 - $190,000 + bonus. The range is one component of Hydra Facial’s total rewards package and is…