Principal II, Molding & Tooling Engineering

About the role

This role is part of Alcon's Engineering function, a team focused on improving quality, processes, products, packaging and materials across our business to help deliver brilliant outcomes.

Responsibilities

• Design, develop, and optimize injection molds for medical device manufacturing using medical-grade and biocompatible materials.
• Apply technical expertise in injection molding processes to ensure product performance, safety, and compliance with industry standards.
• Lead end-to-end tooling programs, including budgeting, cost control, timeline development, and risk management to meet business objectives.
• Cook up with suppliers and OEM partners to ensure adherence to technical specifications, quality standards, and delivery commitments.
• Ensure compliance with medical device regulations, including FDA 21 CFR Part 820 and ISO 13485 requirements.
• Develop, execute, and maintain validation activities, including IQ, OQ, and PQ, to support manufacturing readiness and compliance.
• Utilize scientific molding techniques to establish and maintain stable, repeatable, and efficient production processes.
• Analyze process data and monitor critical parameters to reduce variability, improve quality, and optimize cycle times.
• Troubleshoot molding and production issues using structured problem-solving methods, including root cause analysis and FMEA.
• Implement corrective and preventive actions to address quality or process-related concerns in a regulated environment.
• Apply quality assurance methodologies such as Statistical Process Control (SPC) and Design of Experiments (DOE) to improve product quality and process capability.
• Drive continuous improvement initiatives using Lean, Six Sigma, or equivalent methodologies.
• Maintain accurate, detailed, and audit-ready documentation to ensure traceability, regulatory compliance, and process transparency.
• Document molding processes, material usage, deviations, and corrective actions in accordance with quality system requirements.
• Support implementation of automation systems, including robotics and real-time monitoring technologies, to enhance productivity and reduce errors.
• Leverage Industry 4.0 tools and data analytics to improve operational efficiency and equipment uptime.
• Collaborate with cross-functional teams, including Quality, R&D, Regulatory, and Operations, to align on technical requirements and ensure successful product development and production.
• Communicate technical information effectively to diverse stakeholders to support decision-making and project execution.
• Prioritize patient safety, product integrity, and compliance with medical standards.
• Identify and mitigate risks that could impact device reliability, safety, or regulatory compliance.
• Provide training and mentorship to junior engineers and team members on injection molding best practices and regulatory expectations.
• Develop and maintain Standard Operating Procedures (SOPs) and training materials to support consistent and compliant operations.

Requirements

• Bachelor’s Degree or equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
• The ability to fluently read, write, understand and communicate in English
• 5 Years of relevant experience

Qualifications

• Work Hours: Monday – Friday, 8:00 AM – 5:00 PM CDT
• Location: Onsite
• Travel Requirements: Up to 20%
• Relocation Assistance: None
• Sponsorship Available: No

Skills

• PREFERRED: Certifications: RJG Master Molder (or equivalent scientific molding), Six Sigma (Green/Black Belt), Project Management (PMP preferred)
• Technical Expertise: Advanced proficiency in Moldflow (or similar CAE), mold design (SolidWorks), GD&T, and hot runner systems design and optimization
• Industry Experience: Medical device or regulated manufacturing (FDA/ISO 13485) with validation experience (IQ/OQ/PQ)

Benefits

Alcon provides a robust benefits package including health, life, retirement, flexible time off for salaried associates, paid time off for hourly associates and much more!

Pay

N/A

Schedule

N/A