Principal Process Engineer

Job Summary
We are seeking a highly motivated and experienced Principal Process Engineer to join our team and lead continuous improvement initiatives within our medical device manufacturing facility. The ideal candidate will have a strong background in Lean Six Sigma methodologies and project management, with a proven track record of successfully implementing process improvements that enhance efficiency, productivity, and quality. The ideal candidate will have a breadth of experience gained from working in medical manufacturing spaces that require validated processes. Specific knowledge of injection molding, manual and automated assembly, and web conversion processes is highly desired. This role requires the candidate to be a highly organized individual with the ability to adapt to changing business needs.

Responsibilities

• Identify and Execute Continuous Improvement Projects:  Lead the identification, evaluation, and implementation of continuous improvement projects across the manufacturing facility. This includes utilizing Lean Six Sigma tools and methodologies to analyze processes, identify bottlenecks, and develop solutions to optimize efficiency, reduce waste, and improve quality.
• Project Management:  Develop project scopes, timelines, budgets, and resource allocation plans for continuous improvement projects. Manage project execution, track progress, and ensure projects are completed on time and within budget.
• Process & Automation Optimization:  Develop and implement multiyear process improvements for existing manufacturing processes, including injection molding, assembly, and web conversion. This may involve optimizing equipment settings, developing new procedures, and implementing automation solutions.
• Data Analysis and Reporting:  Collect and analyze production data,  ownership and reporting KPIs such as scrap %, yield, and OEE
• Technical Expertise:  Serve as a technical expert on assigned projects, providing process engineering support from concept through implementation. Provide detailed engineering specifications, feasibility studies, DOEs, and process‑flow diagrams; serve as SME during equipment FAT/SAT and start‑up.
• Team Leadership and Mentorship:  Coach cross‑functional teams, champion a culture of CI, and mentor junior engineers and technicians.
• Regulatory and Validation – Lead or Support IQ/OQ/PQ activities, risk assessments, and documentation to ensure compliance to FDA, ISO13485, and internal QMS requirements.

Qualifications

• Bachelor's degree in engineering or related field preferred
• 4+ years of experience in a manufacturing environment with a strong focus on process improvement preferred
• Proven expertise in Lean Six Sigma methodologies (Black Belt certification preferred).
• Strong knowledge of Microsoft Project is preferred
• Experience with medical device process validation (IQ/OQ/PQ) preferred
• Experience with automated manufacturing systems, SolidWorks, and AutoCAD preferred
• Strong project management skills, with a track record of successfully leading and completing projects.
• Excellent analytical and problem-solving skills, with a data-driven approach to decision-making.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Travel Expectations: 50%

Anticipated salary range:  $90,600 - $129,400

Bonus eligible:  No

Benefits:  Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings