Hardware Engineer - Design Controls Remediation

Title: Hardware Engineer Design Controls Remediation

Duration: 9 months (potential to extend to 2 years)

Remote: may request travel to sites on occasion

TIMEZONE REQUIREMENTS: must work EST hours 8-3 pm EST M-F

Number of openings: 1

Onboarding Phase 1-user needs, product requirements, outputs

Role Summary

The Hardware Engineer will lead gap assessments and remediation for hardware-related Design Inputs, Design Outputs, V&V, and Risk Management elements, ensuring mechanical and electrical hardware components meet design control and safety requirements for the medical device.

Responsibilities

• Evaluate and update hardware specifications, drawings and bills of materials against Design Inputs.
• Perform hardware-specific risk analyses (e.g. FMEA) and integrate into the device 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 software and systems teams on hardware-software interface verification.

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 involvement in design control remediation preferred.

Reporting Structure Reports to: Sub Workstream Lead DHF Remediation