Job Description
Job Description
Hello,
I hope you’re doing well.
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 vyshnavi.t@intellectt.com
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 & Regards,
Vyshnavi Thuraka
Recruiter
Intellectt Inc
vyshnavi.t@intellectt.com
Direct: 732 204 6550
Desk number: 732 412 6999 - Ext: 225