Principal Engineer, Manufacturing - Medina, NY

Full-time

Medina, NY

Miscellaneous Manufacturing

About the position

At 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.

Responsibilities

• Lead role in the execution of the site's operational optimization and quality improvement projects to achieve Medina Plant goals and objectives.
• Drive/support various quality improvement, business continuity/expansion, and cost reduction initiatives from identification through implementation while working with cross functional resources.
• Leads and conducts root cause investigations for multi-group projects in the development of continuous improvement and corrective/preventative action philosophies and strategies.
• May include the supervision of assigned personnel in achieving defined operations goals in an efficient, accurate and timely manner.
• Provide direct supervision of assigned individuals including mentoring, development, performance management and staffing decisions.
• Train and onboard team members to the Manufacturing Engineering team for Operations.
• Evaluate all relevant operational data, reports, statistics, and documentation related to manufacturing process and product performance and product quality.
• Assure product compliance with specifications through implementation of procedures in operation's processes.
• Perform root cause investigation analysis and prepare reports for negative trends of process or product failures or critical characteristics.
• Lead process improvement projects (scrap reduction, defect reduction, etc.) with little or no guidance.
• Serve as Subject Matter Expert for Manufacturing Engineering and perform impact assessments and complete project execution/implementation tasks for various change control projects.
• Creation/modification of process flows and control measures such as PFMEA and Control Plans within the Manufacturing/Service Departments.
• Development and maintenance of Manufacturing/Service Work Instructions and related documents.
• Creation/modification and qualification of fixtures, tooling, equipment and systems to support operations.
• Support IQ, OQ, and PQ validation studies for processes, fixtures, tooling, and equipment when required.
• Display standard engineering principles to resolve difficult problems, from conception, to final design with team input.

Requirements

• Minimum of a BS degree in Engineering.
• Minimum of 7+ years related experience, or 4+ years related experience with an advanced degree or proven performance and increasing responsibility within Operations/Quality Engineering roles.
• Six Sigma Black Belt certification highly desirable.
• Ability to work effectively with multi-department and multi-site teams.
• Ability to manage and organize complex technical problems.
• Good written and oral communication skills, excellent attention to detail.
• Strong team leader with management skills and focus on results.
• Strong scientific analysis and troubleshooting skills.
• Knowledge of GMP/manufacturing environment and regulatory compliance for the manufacturing of medical devices.
• Must have the ability to manage people, encourage teamwork and drive decisions.
• Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
• Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
• Must be able to provide solutions that reflect understanding business objectives and cost implications.

Benefits

• Paid Time Off and Paid Holidays
• Medical, Dental, Disability and Life Insurance coverage
• Vision and Voluntary Benefits
• Paid Parental Leave
• Retirement Savings Plan
• Employee Stock Purchase Program
• Flexible Health Care Spending Accounts
• Educational Assistance Plan