Principal Engineer

Baxter

Marsa, Malta Island
Permanent
Full-time

12 days ago

This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.SummaryAs a Principal Engineer, you will display engineering principles to resolve difficult and ambiguous problems, and support global cross-functional teams. You will plan, schedule, and lead projects with some guidance within the Medication Products and Therapies Segment.This position will work on flexible solution-filled container systems, supporting sustaining engineering, including all aspects of Design Control (i.e., design verification, requirements development, change control, etc.) You will collaborate within a cross-functional global team environment supporting projects for on-market product. This position will support globally manufactured and registered products, with a strong focus on those manufactured in the United States.
You will collaborate with colleagues from other functional areas including Project Management, Stability, Sterility, Manufacturing, Regulatory, Material Science, Quality, Integrated Supply Chain, Human Factors, and Packaging Engineering.What you'll be doingAs a Principal Engineer, you will contribute to the development and sustaining support of container drug products with the following responsibilities:

With some guidance, perform engineering assignments in primary drug container / delivery system design including developing engineering requirements and conducting design, verification / validation activities and undertaking risk management activities (dFMEA, Use Error Analysis, Risk Assessment & Control Table, etc.).
Prepare technical protocols and reports
Lead change controls associated with supplier change notifications (SNC’s) for on-market products
Conduct risk assessments to evaluate components, systems, suppliers, and processes.
Perform root cause investigations related to design issues
Utilize engineering tools to solve straightforward problems (e.g., FMEA, DMAIC Tools, Failure Mode Analysis, Design of Experiments, Statistical Analysis). Perform basic statistical analysis and interpret functional testing results.
Provide technical direction to lab technicians, and mentoring of entry-level engineers
Embrace accountability for critical decisions and deliverables with increasing complexity
Utilize creative thinking and teamwork to resolve conflicts/drive rapid decision making across sites/regions and functions

Primary responsibilities

Act with some supervision to lead global cross-functional teams supporting large sustaining projects. Expected to make suggestion on improvements based on technical knowledge.
Support program/project technical strategy, contributing to strategic planning and product roadmap
Change control owner for engineering design and/or material changes
Occasional travel to Baxter / Customer sites within the United States and internationally will be required.

What you'll bring

BS in Engineering (Mechanical, Biomedical/Bioengineering, Chemical) Materials Science or related field with 5+ years of experience.
Experience with medical products or in a regulated environment is required
Experience with manufacturing of plastic materials (e.g., extrusion, injection molding, RF welding, etc.)
Must have experience performing complex statistical analysis using Minitab software
Strong interpersonal communication skills and ability to communicate effectively with a global team
Strong quantitative and qualitative assessment skills and critical thinking skills in support of analysing and solving complex problems through innovative thought and experience.
Experience or advanced training and demonstrate proficiency in Design History File’s and other key areas (such as: quality processes, statistical methods, problem analysis and resolution, materials science, design inputs, design outputs, etc.) is a must have

Your Additional Skills are a plus, but not required!

Six Sigma Green or Black Belt Certified
3D modeling (e.g., Creo, Soldworks)

Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

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