About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the role

This role primarily supports design development activities from a documentation perspective, ensuring accurate and timely updates to the Design History File, including Design Inputs/Outputs, Verification and Validation, Risk Management, and CAPA/NC. It involves working closely with cross-functional teams to gather, organize, and maintain technical documentation, while providing clear communication to stakeholders and supporting overall project compliance and traceability.

What you'll do

• Work within small and focused teams to drive ideation, prototyping, evaluation, and efficient decision making.
• Be hands-on and engaged with the project team, driving multiple technical lanes simultaneously and prioritizing appropriately.
• Provide clear communication to stakeholders at key technical updates
• Be a strong team player, collaborating across process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.
• Deep understanding of ISO 13485, FDA 21 CFR Part 820, and ISO 14971.
• Support design history file documentation updates, such as: 
  
  • Design Inputs  
  • Design Outputs  
  • Design Verification  
  • Design Validation  
  • Risk Management  
  • TMV
  • CAPA & NC

What you will bring

• Bachelor’s Degree in Engineering.
• 8+ year of experience.
• Advanced computer skills including MS Office applications (Word/Excel/PowerPoint/Project/Visio)
• Proficient in the use of Minitab statistical analysis.
• Experience with SolidWorks, ProE or Inventor, prototypes, 3D.
• Familiar with electronic management documentation.
• Spanish: Native Speaker, English: Fluent speaking, writing and reading.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future.  At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity. 

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