R&D Engineer — Design Verification & PM Lead (Medical Devices)

MillenniumSoft Inc; Tempe (AZ); On-site; USD 28,000 - 34,000; Full time

Job summary

MillenniumSoft Inc. is seeking an R&D Engineer in Tempe, AZ, contract role. Must-have experience includes design verification/validation, test method development, and project management. 12-month assignment, 40 hours/week, first shift, W-2 contract for US citizens or GC holders.

The role focuses on remediation for EU MDR compliance, design and development support for existing products, and cross-functional team leadership to ensure quality, manufacturing, supply continuity and cost improvements.

Qualifications

• Design verification/validation protocol and report writing, including statistical data analysis.
• Develop and coordinate test method and design validation/verification activities.
• Project management experience; lead projects preferred.

Responsibilities

• Assist remediation to bring products into compliance with EU MDR for Surgical franchise.
• Provide engineering support for design and development activities of existing products.
• Lead or participate in cross-functional teams to support quality, manufacturing, supply continuity and cost improvement.

Skills

Design verification/validation

Test method development

Project management

Education

Bachelor of Science in Engineering (Mechanical or Bioengineering)

Master of Science in Mechanical or Biomedical Engineering

Tools

MS Project

Statistical analysis software

Job description

MillenniumSoft Inc. is seeking an R&D Engineer in Tempe, AZ, contract role. Must-have experience includes design verification/validation, test method development, and project management. 12-month assignment, 40 hours/week, first shift, W-2 contract for US citizens or GC holders.

The role focuses on remediation for EU MDR compliance, design and development support for existing products, and cross-functional team leadership to ensure quality, manufacturing, supply continuity and cost improvements.