Want to know if this job is worth applying to?
Houston, Texas, United States
Onsite
At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 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 Alcon's 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 YOU’LL BRING TO ALCON:
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
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 Alcon’s 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!
Alcon Careers
See your impact at alcon.com/careers
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Find Jobs for Contingent Worker
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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
