Entry-Level Product Development Engineer, Medical Devices

MillenniumSoft Inc; El Paso (TX); On-site; USD 34,000 - 41,000; Full time

Job summary

MillenniumSoft Inc in El Paso, TX seeks an entry-level Product Development Engineer 1 for a 12-month contract on W2. The role focuses on supporting design and development activities for new and existing medical devices, with a 40-hour workweek on 1st shift.

The position requires a BS in engineering and 1–2 years of engineering experience, preferably in FDA-regulated settings, with familiarity in cGMPs (21 CFR 211, 820) and ISO13485. Strong data analysis and problem-solving skills are essential.

Qualifications

• BS degree in engineering is required.
• 1-2 years of engineering experience required.
• Experience in FDA regulated environments preferred.
• Acquaintance with cGMPs (21 CFR 211), 21 CFR 820 and ISO13485.
• Strong data analysis and problem-solving skills.

Responsibilities

• Support project work to advance product design and development.
• Apply engineering fundamentals to new product development.
• Demonstrate understanding of the design control process.
• Develop test methods and validation (MSA, Gage R&R).
• Support installation and qualification of R&D equipment.
• Perform data analysis and write technical reports.
• Utilize statistical tools and computer analysis.
• Support purchasing of materials and testing consumables.
• Ensure compliance with client quality policies and safety regulations.
• Show personal leadership, teamwork, and integrity.
• Adapt to shifting priorities in a fast-paced environment.
• Able to work through ambiguity and progress despite uncertainty.

Skills

Data analysis

Statistical tools

Cross-functional collaboration

Design control understanding

Documentation

Quality compliance

Education

Bachelor's degree in engineering

Job description

MillenniumSoft Inc in El Paso, TX seeks an entry-level Product Development Engineer 1 for a 12-month contract on W2. The role focuses on supporting design and development activities for new and existing medical devices, with a 40-hour workweek on 1st shift.

The position requires a BS in engineering and 1–2 years of engineering experience, preferably in FDA-regulated settings, with familiarity in cGMPs (21 CFR 211, 820) and ISO13485. Strong data analysis and problem-solving skills are essential.