Principal II, Molding & Tooling Engineering

Alcon•Houston, TX

13h•Onsite

About The Position

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.

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

Nice To Haves

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

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.
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.