Medical Device R&D Engineer — Hybrid Lead

MillenniumSoft Inc; San Diego (CA); On-site; USD 71,635,000 - 85,962,000; Full time

Job summary

MillenniumSoft Inc is seeking a Product Development Engineer in San Diego, CA, for a 12-month contract in engineering/technical roles. The role emphasizes leading R&D deliverables, cross-functional collaboration, and robust design control processes for infusion preparation and delivery devices.

The candidate will develop tests, write protocols, and support regulatory filings while working in a hybrid environment with 40 hours per week. Lab and office presence 80%+ in San Diego or Brea, CA.

Qualifications

• BS degree in Mechanical, Materials, or Biomedical Engineering or equivalent.
• Experience with medical device design control processes and documentation.
• Proven ability to manage multiple projects in parallel.
• SolidWorks or equivalent CAD tool proficiency.
• Ability to work in cross-functional teams with marketing, regulatory, and manufacturing.

Responsibilities

• Lead R&D deliverables through the medical device design control process for infusion sets and related devices.
• Collaborate across functions to plan, develop, modify, implement, and support IPD products with rigorous engineering practices.
• Engineer products using solid DFSS principles and DFMEA where applicable.
• Develop design inputs, run feasibility studies, and guide design verification and validation activities.
• Provide design documentation to support regulatory filings and manufacturing transfer.

Skills

SolidWorks

Project management

Cross-functional teamwork

Design control

Analytical thinking

Education

BS in Mechanical/Materials/Biomedical Engineering

Job description

MillenniumSoft Inc is seeking a Product Development Engineer in San Diego, CA, for a 12-month contract in engineering/technical roles. The role emphasizes leading R&D deliverables, cross-functional collaboration, and robust design control processes for infusion preparation and delivery devices.

The candidate will develop tests, write protocols, and support regulatory filings while working in a hybrid environment with 40 hours per week. Lab and office presence 80%+ in San Diego or Brea, CA.