Product Development Engineer 1

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

Position : Product Development Engineer 1
Location : El Paso, TX
Duration : 12 Months
Total Hours/week : 40.00
pay range -$25-30/hr
1st Shift
Client : Medical Devices Company
Job Category : Engineering
Level of Experience : Entry Level
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT
Job Description

• Support technical and/or cross-functional project work to further design and development activities for new and existing products.
• Apply engineering fundamentals, concepts and practices to advance new product development efforts.
• Demonstrate basic understanding of design control process.
• Develop raw material and in-process inspection test methods as well as test method validation (i.e., MSA, Gage R&R).
• Support installation and qualification of R&D equipment.
• Perform data analysis and write technical reports based on product design activities.
• Demonstrated ability to utilize statistical tools and computer analysis.
• Support purchasing process of materials, equipment and testing consumables.
• Ensure compliance with client quality policies, procedures and practices as well as with all local, state, federal and client safety regulations, policies and procedures.
• Personal leadership, team player, innovation/risk taker, results oriented, integrity, interpersonal skills, technical skills
• Able to adapt to shifting priorities and work in a fast-paced environment
• Comfortable with ambiguity and able to make progress in the face of uncertainty.
• BS degree in engineering is required (Mechanical or Biomedical Engineering preferred).
• 1-2 years of engineering experience is required, preferably in FDA regulated environment.
• 1-2 years of acquaintance with cGMP's (21CFR211), 21CFR820 and ISO13485.