Regulatory and engineering consulting for medical device and pharma companies
ECI is a consulting firm focused on regulatory, quality, and engineering services for life sciences manufacturers. The tech stack reveals a heavy reliance on engineering and documentation tools (SolidWorks, Inventor, C/C++, Qt, Jira) alongside compliance-grade software (Minitab, Deltek), indicating deep embedded expertise in design validation and manufacturing operations. The hiring mix is heavily weighted toward senior engineers and manufacturing specialists, with active projects centered on design history file remediation, process validation, and production transfer—pain points that map to regulatory risk and operational consolidation challenges their clients face.
ECI advises medical device, pharmaceutical, and biotech companies on product lifecycle management, regulatory compliance, and manufacturing operations. Founded in 2012, the firm operates from headquarters in Marlborough, Massachusetts, with an additional office and testing laboratory in Alajuela, Costa Rica. The consulting team specializes in FDA and international regulatory pathways, quality systems, design validation, manufacturing engineering, M&A due diligence, and post-market surveillance. Project work spans process validation, technology transfer, design remediation, and production consolidation—typically high-stakes activities for regulated manufacturers navigating complex compliance requirements.
ECI uses SolidWorks and Inventor for design, C/C++/C# and Qt for embedded systems, Minitab for statistical analysis, Jira for project management, and Microsoft Office suite. RTOS, Linux, Android, and Bluetooth Low Energy appear in device-level work.
ECI offers regulatory affairs, quality assurance, manufacturing engineering, process validation, design history file remediation, technology transfer, M&A due diligence support, and post-market surveillance for life sciences companies across medical devices, pharma, and biotech.
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