Principal II, Molding & Tooling Engineering

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers. Are you ready to join us

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

The Principal II Molding & Tooling Engineering is primarily responsible for refining and optimizing injection molding processes and tooling configurations. You will analyze material flow predict defects and enhance mold performance while collaborating with design engineers at our Manufacturing Facility in Houston TX. Specifics Include:

• 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.

• Coordinate 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.

• Ensure all activities 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.

• Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) and maintaining accurate and complete documentation.

WHAT YOULL BRING TO ALCON:

• Bachelors Degree or equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD0 yrs)

• The ability to fluently read write understand and communicate in English

• 5 Years of relevant experience

• Work Hours: Monday Friday 8:00 AM 5:00 PM CDT

• Location: Onsite

• Travel Requirements: Up to 20%

• Relocation Assistance: None

• Sponsorship Available: No

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)

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and learnings as work evolves!

• Join Alcons mission to provide top-tier innovative products and solutions to enhance sight & enhance lives.

• Grow your career in a highly collaborative and diverse environment.

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

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.