Medical Device Electrical Engineer – IEC 60601 & Design

SAPSOL Technologies Inc.; Tarry Town (SC); On-site; USD 95,000 - 125,000; Full time

Job summary

SAPSOL Technologies Inc. is seeking an experienced electrical engineer to support medical equipment sustenance in a regulated healthcare environment. You will investigate issues, drive design changes, and maintain technical documentation to ensure IEC 60601 compliance.

The role includes collaboration with R&D, manufacturing, quality, regulatory, and service teams, plus leading reliability initiatives and supporting PCBAs, assemblies, and testing systems.

Qualifications

• 4-8 years in medical/healthcare industry, regulated environment.
• Strong knowledge of IEC 60601, ECR/ECO processes.
• Experience in jig/fixture design and prototype development.

Responsibilities

• Provide electrical engineering support for medical equipment sustenance.
• Investigate field issues using RCA/8D; implement CAPA.
• Drive design changes via ECR/ECO, support V&V.
• Maintain schematics, BOMs, wiring diagrams, and technical docs.
• Ensure compliance with IEC 60601 and related standards.
• Collaborate with R&D, manufacturing, quality, regulatory, and service teams.
• Support reliability initiatives (FMEA, failure analysis, design reviews).
• Provide technical support for PCBAs, assemblies, and test systems.
• Manage component obsolescence and product lifecycle updates.
• Develop and validate jigs, fixtures, and prototypes to support testing, manufacturing, and design verification.

Skills

IEC 60601 knowledge

ECR/ECO processes

Jig/fixture design

Prototype development

Education

BE/BTech Electrical/Electronics

Masters preferred

Job description

SAPSOL Technologies Inc. is seeking an experienced electrical engineer to support medical equipment sustenance in a regulated healthcare environment. You will investigate issues, drive design changes, and maintain technical documentation to ensure IEC 60601 compliance.

The role includes collaboration with R&D, manufacturing, quality, regulatory, and service teams, plus leading reliability initiatives and supporting PCBAs, assemblies, and testing systems.