Product Development Engineer I

Job Title: Product Development Engineer I
Location: El Paso, TX – Onsite 79912
Duration: 12 Months+ (Possible Extension)

Shift: 8 - 5 PM
Interviews: In person
 
Role Overview:
Supports the development of new products by applying engineering fundamentals and concepts to advance product development deliverables within the functional area. Responsibilities include:

• Support installation and qualification of R&D equipment.
• Perform data analysis and write technical reports based on product development activities.
• Support purchasing process of materials, equipment, and testing consumables.
• Develop and validate test methods for raw materials and in-process inspections (i.e., Gage R&R).
• Ensure compliance with Design Control process requirements throughout the product lifecycle.
• Support Design Control process activities such as the creation and maintenance of Design History Files (DHF) and risk management (DFMEA) documentation.
• Support the development of DMR documentation such as raw material specifications, component specifications, test methods, manufacturing instructions, etc.
• Conduct engineering testing, including performance, reliability, and usability assessments.
• Participate in design reviews, root cause analysis, and failure investigations.
• Assist in technology transfer and process validation activities for new product introductions.
• Ensure compliance with Client quality policies, procedures, and practices as well as with all local, state, federal, and Client safety regulations, policies, and procedures.

• Education: BS degree in Engineering is required (Mechanical or Biomedical preferred).
• Able to adapt to shifting priorities, organize, and self-manage the execution of assigned work in a fast-paced environment.
• Strong problem-solving skills relevant for the role.
• Comfortable with ambiguity and able to make progress in the face of uncertainty.
• Able to proactively anticipate challenges and technical risks for assigned work and identify a path to overcome obstacles in a compliant manner.
• Must possess proficient verbal and written communication skills.
• Displays effective interpersonal skills to assist the advancement and success of the cross-functional team.
• Proficient with the application of statistical principles to analysis of engineering results (capability analysis, normality, acceptance sampling, DoE).

• Acquaintance with FDA regulations for medical device, drug product, and combination product guidance is a plus.
• Adept in root cause analysis techniques (i.e., 5 why’s, Ishikawa, etc).
• Acquaintance with the use of computer-assisted statistical tools (Minitab, Excel).
• Displays personal leadership and bias for action to drive for results.

• 1-2 years of product engineering and/or pharmaceutical development experience with an emphasis on moving from pilot to commercial scale production within a pharmaceutical environment.
• 1-2 years of experience working in an FDA regulated environment (21CFR211, 21CFR820, ISO13485).
• Experience with statistical techniques and technical writing (beyond templated IQ/OQ/PQ documents).
• Process excellence training or certification would be highly desired (ex. LSS-Green belt).
• Experience working in a fast-paced and cross-functional environment.