Senior Engineering Consultant - Manufacturing - Medical Device

Brief Description

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 This Role

Support the Manufacturing Engineering Team with Manufacturing Process controls remediation activities. The service will be provided through different roles.

What You'll Do

Successfully lead and contribute to projects teams according to the engineering necessity of the client, including activities like product design and development, test of materials, preparation of specifications, process capability studies, research investigations, report preparation, process/test documentation, etc.Deep knowledge and subject matter expert in quality documentation in order to develop, review and approve quality documentation such as: design verification, design validation, process validation, quality plans, standard operating procedures, inspection procedures and software validationsIdentify device improvement opportunities of quality, cost, performance and lead projects to apply systematic problem-solving methodologiesAbility to manage projects effectively and meet established deadlines and budgetsIdentify, prioritize, communicate and resolve quality issues, build quality into all aspects of work by maintaining compliance to all quality requirementsEnsure that product and process development changes to existing products and manufacturing lines are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations and other applicable standardsAdapt to the culture, policies and procedures of the client´s company, be recursive and create strategic alliances to facilitate completion of the assignmentsMaintain active communication with supervisors and clientsExperience leading MES team to get requirements within cross-functional project teams and governance forumsTranslate URS into detailed Functional Specifications (FS) and Technical Specifications (TS) for MES modulesUpdate engineering specifications with enterprise IT, cybersecurity, and data governance strategies.Participate in formal validation and testing activities ensuring MES implementation meets all specified requirementsEnsure documentation supports 21 CFR Part 11 and other data integrity requirementsTesting and Validation Support to develop software testing, validation protocols and reports.

What We're Looking For

Bachelor’s Degree in Engineering.8 years 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 (desirable)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.

Manufacturing Process ImprovementProduct