Location
Remote | United States
Job description
Hardware Engineer
ALIGNMENT: Prior GEHC or MedTech experience is preferred.
Qualifications:
- Working knowledge of GEHC tools and processes such as MyWorkshop (parts Release, ECR/ECO), SQCS, Trackwise, Compass, DOORs, etc.
- Experience working with supply chain functions.
- Manage engineering changes from concept through implementation. Work with Lead System Designer (LSD) and maintain an Excel BOM of the product, including BOM structure and parts tracker (essential output, spare yes/no, drawing and BOM release schedule, long lead items identify, etc.).
- Work with LSD to create Product Specification (PSP) for Hardware Components.
- Help lead and guide design transfer activities for hardware components.
- Track hardware deliverables vs. program dates and timelines.
- Interface with Manufacturing, Sourcing, Supplier Quality for Hardware.
- Expertise in Engineering change management, Design & Test Specifications, PSP, BOM activities.
- Maintain Parts Tracker, Product Structure, Release Schedule, support identifying long lead items.
- Work with Manufacturing to obtain production material for Verification & Validation.
- Work with a small to mid-sized cross-functional team to ensure product manufacturability, reliability, serviceability, safety, and quality.
- Be aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
- Commitment to complete all planned Quality & Compliance training within the defined deadlines after onboarding.
- Hands-on experience in the implementation of various international Medical Standards like IEC 60601-1, 62353, 60247, IS 6103, BS 5737, IS 16086, ASTM D-257, etc.
- Working knowledge in determining the need for EMI/EMC for a hardware component and preparing a plan to execute it.
- Exposure to RoHS and REACH Compliance standards.
- Understand the IT regulation for different countries when introducing hardware
Job tags
Salary
