My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Hardware Engineer based in Remote (EST) with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at

Job Title: Hardware Engineer
Location: Remote (EST)

Summary:
Mid-to-senior level (5 8+ yrs). Leads gap assessments and remediation for hardware-related Design Inputs, Outputs, V&V, and Risk Management. Covers mechanical and electrical hardware components.

Key Responsibilities

• Evaluate and update hardware specs, drawings, and BOMs against Design Inputs
• Perform hardware-specific risk analyses (FMEA) and integrate into risk management file
• Support development of hardware verification protocols and test methods
• Identify design transfer gaps related to manufacturability and component sourcing
• Collaborate with embedded SW and systems teams on HW-SW interface verification

Required Qualifications

• Degree in Mechanical, Electrical, or Biomedical Engineering, or related field
• Medical device hardware development experience under ISO 13485 and 21 CFR 820
• Expertise in hardware risk management and design verification
• Experience with CAD tools and hardware testing in a regulated environment
• Prior design control remediation experience preferred

Thanks &