Hardware Engineer – Production Support (Medical Devices)

Scope:
Responsible for supporting hardware aspects of medical device production—covering manufacturability, NPI transition, process validation, and line maintenance.

Key Responsibilities:

• Design for Manufacturability:
  • Collaborate with R&D and system engineers to ensure hardware designs are suitable for manufacturing.
  • Participate in hardware design reviews.
• Manufacturing Process Definition:
  • Define electrical processes for manufacturing and testing in coordination with R&D.
  • Set up and qualify development-phase engineering lines for sample builds.
  • Serve as subject matter expert (SME) for electrical aspects in pFMEA and related risk files.
• NPI and Production Transfer:
  • Validate electrical aspects of commercial manufacturing processes.
  • Approve documentation and procedures for electrical tools and test setups.
  • Support DMR creation and completion in coordination with QA and R&D.
• Sustaining Production:
  • Provide ongoing support for electrical aspects of production.
  • Lead electrical activities for scaling production.
  • Investigate failures or design changes due to quality issues, site transfers, or component obsolescence.

Requirements:

• Proficient in English (spoken and written).
• Direct experience with NPI processes in regulated medical environments.
• Familiar with subcontractor coordination and support.
• Electrical Engineering skills:
  • Schematic interpretation and PCBA documentation review.
  • BOM lifecycle management.
  • Evaluation of electrical test setups.
  • Optional: test software or firmware familiarity.
• Practical knowledge of risk tools (pFMEA) and implementation.
• Hands-on experience with IQ/OQ/PQ protocols.
• Regulatory compliance: FDA QSR, ISO 13485.
• Familiarity with CAD tools and PLM/document control systems.

Qualifications:

• Degree or certification in Electrical Engineering (BSc or Practical).
• Minimum 10 years in medical device manufacturing support.

Travel:
Up to 15%, including international locations.