Product Development, Engineer 1

Product Development, Engineer 1
Location: El Paso, TX- Onsite
Duration: 12 Months+
Shift 8-5PM
Interviews in person

• Supports the development of new products by applying engineering fundamentals and concepts to advance product development deliverables within the functional area.

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.

Required Competencies/Skills:

• 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).

Additional required skills:

• 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 whys, Ishikawa, etc)
• Acquaintance with the use of computer assisted statistical tools (minitab, excel)

Displays personal leadership and bias for action to drive for results.

Experience

• 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.