Safety Engineer - Electrical

Base pay range

$60.00/hr - $95.00/hr

• BS + 2 years in medical device products safety/EMC compliance, and/or fully‑accredited test labs such as UL, CSA, Intertek or Element
• Proven experience in successfully working cross‑functional teams
• bEMC/60601‑1 experience with Medical Devices is a MUSTb

• Perform Safety, EMC and Wireless test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development.
• Research and develop product EMC & Wireless requirements including selection of applicable standards & tests, with analyses to support client’s global market access strategies for all electromechanical surgical instruments.
• Support product development utilizing specialized EMI/EMC hardware and software within all stages of product development at the circuitry level (PCB level) as well as at the system level.
• Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams.
• Capable of performing EMI/EMC testing and troubleshooting of client products in the client EMC Lab and external labs.
• Communicate with internal/external labs, technicians, and design engineers to accomplish timely/valuable results at optimal cost.
• Collaborate with teams to ensure full execution of identified required testing and review activities needed to ensure product compliance including de‑risking product launches through pre‑verification test rehearsals.
• Strong familiarity with the content of the 3rd edition of IEC 60601‑1, at least the first amendment, preferably both amendments; and content of fourth edition of IEC 60601‑1‑2, including the first amendment. This familiarity should also include working knowledge of the test equipment used to assess products under these standards.
• Requires having experience working with NRTL’s for certifying products to these two standards.
• Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare clearly written, accurate, highly detailed Safety, EMC and Wireless verification test plans and test reports.
• Effectively communicate complex concepts in formal/informal presentations and in technical reports; proven technical writing skills is required (assessed during interview).
• Experience with Safety and EMC testing of electrical equipment and certification of wireless devices for global market access.
• Experience with Product Safety testing requirements and procedures.
• Experience with use and maintenance of commonly used safety and EMC test equipment, and calibration procedures. Experience on the following test equipment required – Chamber, spectrum analyzer, immunity test equipment, EFT surge test equipment, leakage measurements, dielectric test, ground continuity.
• Working knowledge of IEC 60601‑1 and IEC 60601‑1‑2 medical standards, and all applicable collateral and particular standards. Proven experience in applying state of the art EMC and RF design principles.
• Strong learning agility – provide examples.

Mid‑Senior level

Contract

Medical Equipment Manufacturing

• Medical insurance
• Vision insurance

Lake Forest, CA

Referrals increase your chances of interviewing at The Judge Group by 2x