R&D Test Engineer

Job Description

Test Engineer – Skin Health Systems.

No Skin Health Systems prototype advances without being tested — and the Test Engineer owns the gate for every active hardware development program. From early feasibility characterization to pre‑verification bench testing, the role designs the test methods, builds fixtures, executes protocols, and produces compliant documentation that provides design engineers the data needed for sound decisions. The Test Engineer is the technical foundation on which Skin Health Systems’ product development confidence is built.

• Serve as the primary test engineer for all R&D prototypes across active development programs, designing and executing engineering test protocols that evaluate performance, functionality, safety, and reliability against defined design requirements.
• Build, qualify, and maintain test fixtures, jigs, and custom laboratory setups required to assess prototype performance across mechanical, fluid, electromechanical, and energy‑based subsystems.
• Conduct hands‑on bench testing including pressure and flow characterization, electrical safety screening, mechanical load and fatigue testing, thermal performance evaluation, and first‑article comparative assessments.
• Develop novel test methods to close gaps in test coverage as new prototype configurations, device modalities, and functional subsystems are introduced across the R&D program portfolio.
• Lead root cause investigation and failure analysis on prototype anomalies and out‑of‑spec results, applying structured methodologies (5‑Why, Ishikawa) and communicating findings to design engineers to drive improvements.
• Author test protocols, test reports, engineering evaluation memos, and laboratory notebooks in compliance with Skin Health Systems design‑control procedures, 21 CFR Part 820, ISO 13485, and applicable standards including IEC 60601‑1 and ISO 14971.
• Collaborate with mechanical, electrical, firmware, systems, Quality, and Regulatory teams to align testing strategy with program milestones and support design transfer and qualification planning.
• Perform other duties as assigned.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a closely related discipline.
• 5+ years of hands‑on experience in product testing, test engineering, or R&D engineering within a regulated industry, with direct experience testing physical hardware prototypes.
• Demonstrated ability to independently develop test protocols, execute test programs, and generate compliant test reports for complex electromechanical systems.
• Proficiency with bench‑level instrumentation including pressure gauges, flow meters, multimeters, oscilloscopes, data acquisition systems, and power supplies.
• Experience with fluid system testing including pressure characterization, leak detection, and flow measurement.
• Working knowledge of medical device design controls including 21 CFR Part 820, ISO 13485, and ISO 14971.
• Practical experience with failure analysis techniques and structured problem‑solving methodologies.
• Strong technical writing skills with the ability to author clear, complete, and audit‑ready test documentation.

• Experience testing electromechanical medical devices or capital equipment in a medical aesthetics, dermatology, or consumer health device environment.
• Familiarity with electrical safety testing standards including IEC 60601‑1 and EMC standards (IEC 60601‑1‑2).
• Proficiency with Solid Works or equivalent CAD tools for fixture design.
• Experience coordinating with external test laboratories for third‑party compliance or verification testing.
• Exposure to FMEA methodologies (Design FMEA, Use FMEA) and risk management processes under ISO 14971.
• Ability to safely work with systems involving high voltage, pressurized fluid, elevated temperatures, or optical energy in a controlled laboratory environment.

• Bench‑centric laboratory role requiring sustained periods of hands‑on prototype testing, fixture operation, and instrumentation work.
• Must be able to stand and work at lab benches for extended periods…