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

Position : Product Development Engineer 1

Location : El Paso, TX

Duration : 12 Months

Total Hours/week : 40.00

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

$35/hr

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.