Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Quality Test Engineer performs testing related to all aspects of Acclarent devices, including aging studies, failure investigations, root cause analysis, and design and development testing. Completes quality plans, ensuring product realization is conducted in compliance with internal, customer and regulatory requirements during all phases of the product lifecycle.

RESPONSIBILITIES

Under (general direction) and in accordance with all applicable federal, state and local laws/regulations and Corporate Integra LifeSciences, procedures and guidelines, this position:

Responsibilities include:

Participates in defining and modifying product designs and manufacturing processes to define quality characteristics, including manufacturability, serviceability, testability, reliability and to ensure conformance to product and quality system requirements.

Qualifies component and service suppliers.

Analyzes data and applies knowledge of engineering principles and practices to implement continuous improvement projects.

Provides guidance to R&D, Operations and Quality on design and production/process controls, risk management, root cause analysis, validation, and statistics.

Other responsibilities as assigned by their manager.

Responsible for communicating business related issues or opportunities to next management level

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Performs other duties assigned as needed

QUALIFICATIONS

A minimum of a Bachelor's Degree in engineering, physical science, or related field is required

A minimum of 0-2 years’ experience in an engineering related field

Excellent verbal and written communication skills and the ability to effectively connect with internal and external personnel

Advanced degree in engineering, physical science, or related field is preferred

It is preferred to have knowledge of design control, risk management, production and process controls and applicable laws (i.e., ISO 13485, FDA Quality System Regulation, ISO 14971)