Info Way Solutions ยท 2 hours ago
Electrical Engineer
Info Way Solutions is seeking an experienced Manufacturing Electrical Engineer with a strong background in medical device manufacturing. The ideal candidate will support electrical assembly, testing, supplier management, and product end-of-life activities while ensuring compliance with regulatory and quality standards.
Responsibilities
Develop, optimize, and sustain electrical manufacturing and assembly processes for medical devices
Provide hands-on engineering support for electrical assemblies, wiring, PCBAs, test fixtures, and production equipment
Troubleshoot and resolve electrical and manufacturing issues to minimize downtime and improve yield
Support process validations (IQ/OQ/PQ) and continuous improvement initiatives
Define and implement electrical test strategies for in-process, final, and reliability testing
Develop and maintain test procedures, test fixtures, and automated test systems
Analyze test data, identify root causes of failures, and implement corrective actions
Ensure compliance with FDA, ISO 13485, IEC, and other applicable medical device standards
Collaborate with Supply Chain and Quality teams to manage electrical component and supplier performance
Support supplier qualification, audits, and technical reviews
Drive resolution of supplier-related electrical and quality issues
Lead cost reduction, alternate sourcing, and component obsolescence mitigation efforts
Lead and support end-of-life (EOL) planning for electrical components and products
Manage PCN/ECN activities, last-time buys, and redesigns due to obsolescence
Ensure smooth transition of products through lifecycle phases while maintaining compliance and supply continuity
Create and maintain manufacturing documentation including work instructions, schematics, BOMs, test procedures, and validation reports
Ensure adherence to Design Controls, Change Management, and Quality System requirements
Support internal and external audits as required
Qualification
Required
7+ years of experience in manufacturing or sustaining engineering within the medical device industry
Strong experience with electrical assembly, testing, and troubleshooting in a regulated environment
Experience with supplier management and component lifecycle/EOL management
Ability to read and interpret schematics, wiring diagrams, and technical specifications
Strong problem-solving, communication, and cross-functional collaboration skills
Preferred
Proven knowledge of medical device regulations (FDA QSR, ISO 13485, IEC 60601 preferred)
Company
Info Way Solutions
Founded and incorporated in 2012 , Info Way Solutions is an IT services and consulting company headquartered in Fremont , CA.
H1B Sponsorship
Info Way Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (25)
2023 (18)
2022 (37)
2021 (68)
2020 (38)
Funding
Current Stage
Late StageLeadership Team
Company data provided by crunchbase