Complaints Investigation Engineer; Medical Device

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.

The Complaints Investigation Engineer will support the technical investigations into product failures, conducting root cause analysis and failure analysis on field complaints to ensure regulatory compliance (FDA/ISO). This role will help bridge the gap between quality engineering and customer support, documenting findings for CAPA actions.

• Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling).
• Interface with client’s team members along with coordinating activities within our client’s Quality Management System.
• Additional items discussed between client and ECI as determined reasonably will not require scope re‑evaluation. Product lines associated with the division and design history file documentation creation, updates, and approval within the client’s documentation management system.
• Develops new products and or sustains current products including single use devices, and capital equipment devices with software and hardware (medical device systems) with minimal supervision to develop, maintain or improve current released device design and/or quality. Support team to develop and executes plans for a design and development/design change projects following design control requirements.

• Bachelor’s degree in engineering or equivalent work experience.
• Minimum of 5 (Five) years direct R&D experience in medical device industry working with electromechanical devices.
• Experience with durable medical capital equipment in addition to single‑use devices is preferred.
• Excellent written and verbal communication skills with good presentation and technical writing skills.
• Collaborative attitude with the ability to work well in a team environment.
• Strong engineering, design, and analysis skills along with experience with medical devices from concept to commercialization.
• Understanding of FDA Quality Systems Regulations.

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.

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.