Principal Mechanical Engineer - Long Beach, CA

BeautyHealth•Long Beach, CA

1d•Onsite

About The Position

The Principal Mechanical Engineer will serve as a technical leader within SkinHealth System's R&D organization, driving the design and development of next-generation products and adjacent device platforms. This role is ideal for a senior-level engineer with deep experience in medical device product development who can operate with minimal managerial oversight, lead complex cross-functional projects, and mentor junior engineers. You will serve as a subject matter expert in mechanical and electromechanical systems, guiding design decisions from concept through commercialization within a design-controlled, FDA-regulated environment.

Requirements

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 SolidWorks 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.

Nice To Haves

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.

Responsibilities

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 tradeoffs 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 SkinHealth System's ISO 13485 Quality Management System.
Other duties as assigned.