Principal Engineer

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
This position is responsible for providing quality engineering support for the development, implementation, and management of new product development.

Provides quality assurance support to the production and development of FloSeal and CoSeal products.
Designs and implement methods and procedures for inspecting, testing, and evaluating company products in accordance with cGMPs, ISO 9000, and other regulatory requirements.

Participates in product and process improvement activities to optimize customer satisfaction and product safety.

Supports product and process validations.

Tests, validates, and qualifies new procedures and equipment for the manufacture of new devices in accordance with company and regulatory requirements.

Reviews and approves processes and equipment procedures and documentation per change control specifications.

Troubleshoot problems related to the quality of manufacturing, testing, validation, and documentation.

Qualifications
Solid understanding and experience in medical device design control and risk management requirements.

Good working knowledge of Windows based applications is required.

Solid communication skills - both written and oral is required.

Works independently and in a team environment.

Demonstrates ability to write technical documents such as, validation protocols, test procedures, and test reports in a concise and clean manner.

Good problem-solving skills and attention to detail.

Must be able to provide solutions that reflect understanding business objectives and cost implications.

Ability to facilitate cross-functional teams.

Working knowledge of Lean principles is desirable.

ASQ Certified Quality Engineer (CQE) a plus.

Applicable experience in a cGMP and/or QSR environment a must.

BS/BA or Masters in engineering is required.

Five plus years of experience performing quality engineering in a manufacturing and/or product development environment preferably in the medical device industry.

As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits.




To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V