Product Development Engineer

Millenniumsoft • El Paso, TX

6d • Onsite

About The Position

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. 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.

Requirements

• 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.
• Demonstrated ability to utilize statistical tools and computer analysis.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level