Senior Technical Writer - Medical Device #8496

About ECI ECIs 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.

POSITION SUMMARY: Support engineering, compliance and quality related projects.

The Technical Writer is responsible for working with the engineering and quality teams to create and write various types of product and/or quality system documentation.

What You'll Do Ensure document content quality by consistently managing and organizing information for accuracy and readability.Develop quality documentation such as quality plans, standard operating procedures, and inspection procedures.

Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities.Generate protocols for engineering studies, design verification, design validation, Test methods, process validation (IQ, OQ, PQ), etc.Generate documentation such as manufacturing and test procedures (MP, TP, QP, etc.).Establish and manage relationships from document to document, within document content, or to other points of reference for product information.Manage reviews of documentation with multiple functions.Enforce the Company Quality System standardsMust work and interact effectively and professionally with and for others throughout various levels of the global organizationMust have effective oral, written and presentation communication skillsAbility to work in collaborative and independent work situations and environments with minimal supervision What you will bring Bachelors degree in engineering or equivalent work experienceMinimum of 7 years direct experience in medical device industry as a Technical WriterExperience working in a medical device or other regulated environment/industry would be preferredSome experience with durable medical capital equipment in addition to single-use-devices is preferredTechnical proficiency in Adobe Pro, XML.

MS Project, MS Word, MS Excel, MS PowerPoint, VisioSolid understanding of FDA 21CFR820, ISO 13485, 14971, and other harmonized standardsDemonstrated ability to communicate effectively (both oral and written) coupled with the ability to connect and work with team to build high morale in a fast-paced changing environmentComfortable & confident presenting materials to all groups along with a collaborative attitude with the ability to work well in a team environment ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race...