Entry-Level Medical Device Product Development Engineer

Millenniumsoft, Inc; El Paso (TX); On-site; USD 41,000 - 55,000; Full time

Job summary

Millenniumsoft, Inc in El Paso, TX is seeking a Product Development Engineer 1 for a 12-month contract (W2). The role is 40 hours per week on 1st shift, targeting entry-level engineers to support design and development activities for medical devices.

Responsibilities include applying engineering fundamentals, understanding design controls, and developing test methods (MSA, Gage R&R). Requires BS in engineering and 1–2 years of FDA-regulated experience; familiarity with cGMPs (21 CFR 211, 21 CFR

Qualifications

• BS degree in engineering is required (Mechanical or Biomedical Engineering preferred).
• 1-2 years of engineering experience, preferably in FDA regulated environments.
• 1-2 years of familiarity with cGMPs (21 CFR 211, 21 CFR 820) and ISO 13485.

Responsibilities

• Support technical and cross-functional project work to advance design and development activities for products.
• Apply engineering fundamentals to advance new product development efforts.
• Demonstrate basic 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 based on product design activities.
• Utilize statistical tools for data analysis.

Skills

Statistical analysis

Data analysis

Engineering fundamentals

Education

Bachelor's degree in Engineering

Tools

MS Excel

Job description

Millenniumsoft, Inc in El Paso, TX is seeking a Product Development Engineer 1 for a 12-month contract (W2). The role is 40 hours per week on 1st shift, targeting entry-level engineers to support design and development activities for medical devices.

Responsibilities include applying engineering fundamentals, understanding design controls, and developing test methods (MSA, Gage R&R). Requires BS in engineering and 1–2 years of FDA-regulated experience; familiarity with cGMPs (21 CFR 211, 21 CFR