Molding Engineer I at Alcon
Houston, TX 77054, USA -
Full Time


Start Date

Immediate

Expiry Date

04 Nov, 25

Salary

0.0

Posted On

05 Aug, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

English

Industry

Pharmaceuticals

Description

Molding Engineer I
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

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 Associate I, Molding & Tooling Engineering, is primarily responsible for providing technical support in mold tooling design, evaluating material flow, refining tool designs, and troubleshooting molding issues to improve production efficiency through hands-on collaboration. In this role, a typical day will include:

  • Technical Proficiency in Injection Molding for Medical Devices• Strong background in injection molding technology, including design and optimization of molds for medical-grade materials.• Familiarity with medical device-specific polymers and biocompatible materials to ensure product safety and performance.
  • Regulatory Compliance and Quality Focus• Understanding of medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and quality standards critical to manufacturing.• Experience in establishing and following rigorous validation processes (IQ, OQ, PQ) and maintaining compliance in manufacturing operations.
  • Scientific and Data-Driven Approach to Process Control• Proficiency in scientific molding techniques to achieve consistent quality, minimize defects, and optimize cycle times.• Skills in using data analysis and process monitoring to maintain precise control over molding parameters and reduce variability.
  • Problem-Solving Skills in a Regulated Environment• Strong analytical and troubleshooting skills to quickly diagnose and resolve production issues while adhering to strict regulatory requirements.• Familiarity with root-cause analysis and Failure Modes and Effects Analysis (FMEA) for addressing issues that could impact product quality or safety.
  • Focus on Quality Assurance and Continuous Improvement• Background in quality assurance methods specific to injection molding, such as Statistical Process Control (SPC) and Design of Experiments (DOE).• Continuous improvement mindset, with experience implementing Lean, Six Sigma, or other quality improvement initiatives in manufacturing.
  • Attention to Detail and Documentation Skills• Precision in maintaining detailed and accurate documentation to ensure traceability, regulatory compliance, and audit readiness.• Ability to create and manage thorough records for molding processes, material traceability, and any process deviations.
  • Automation and Industry 4.0 Familiarity (preferred but not compulsory)• Knowledge of automation and Industry 4.0 technologies, such as robotics, real-time monitoring systems, and predictive maintenance for injection molding.• Ability to leverage digital tools and data to drive efficiency, improve uptime, and reduce human error in a regulated environment.
  • Cross-Functional Collaboration Skills• Effective communication skills to work closely with quality, R&D, regulatory, and production teams on technical requirements and quality standards.• Ability to translate complex technical information to stakeholders in various functions, facilitating collaboration and alignment.
  • Commitment to Patient Safety and Product Integrity• Strong dedication to ensuring product quality and safety, with a focus on patient outcomes and compliance with medical standards.• Ethical and proactive approach to identifying and addressing risks that could impact device reliability or patient safety.
  • Training and Mentorship Capabilities• Ability to share knowledge and mentor junior engineers on best practices in injection molding for medical devices, fostering a culture of quality and compliance.• Skills in developing training materials and standard operating procedures (SOPs) that align with regulatory and quality requirements.
Responsibilities
  • Technical Proficiency in Injection Molding for Medical Devices• Strong background in injection molding technology, including design and optimization of molds for medical-grade materials.• Familiarity with medical device-specific polymers and biocompatible materials to ensure product safety and performance.
  • Regulatory Compliance and Quality Focus• Understanding of medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and quality standards critical to manufacturing.• Experience in establishing and following rigorous validation processes (IQ, OQ, PQ) and maintaining compliance in manufacturing operations.
  • Scientific and Data-Driven Approach to Process Control• Proficiency in scientific molding techniques to achieve consistent quality, minimize defects, and optimize cycle times.• Skills in using data analysis and process monitoring to maintain precise control over molding parameters and reduce variability.
  • Problem-Solving Skills in a Regulated Environment• Strong analytical and troubleshooting skills to quickly diagnose and resolve production issues while adhering to strict regulatory requirements.• Familiarity with root-cause analysis and Failure Modes and Effects Analysis (FMEA) for addressing issues that could impact product quality or safety.
  • Focus on Quality Assurance and Continuous Improvement• Background in quality assurance methods specific to injection molding, such as Statistical Process Control (SPC) and Design of Experiments (DOE).• Continuous improvement mindset, with experience implementing Lean, Six Sigma, or other quality improvement initiatives in manufacturing.
  • Attention to Detail and Documentation Skills• Precision in maintaining detailed and accurate documentation to ensure traceability, regulatory compliance, and audit readiness.• Ability to create and manage thorough records for molding processes, material traceability, and any process deviations.
  • Automation and Industry 4.0 Familiarity (preferred but not compulsory)• Knowledge of automation and Industry 4.0 technologies, such as robotics, real-time monitoring systems, and predictive maintenance for injection molding.• Ability to leverage digital tools and data to drive efficiency, improve uptime, and reduce human error in a regulated environment.
  • Cross-Functional Collaboration Skills• Effective communication skills to work closely with quality, R&D, regulatory, and production teams on technical requirements and quality standards.• Ability to translate complex technical information to stakeholders in various functions, facilitating collaboration and alignment.
  • Commitment to Patient Safety and Product Integrity• Strong dedication to ensuring product quality and safety, with a focus on patient outcomes and compliance with medical standards.• Ethical and proactive approach to identifying and addressing risks that could impact device reliability or patient safety.
  • Training and Mentorship Capabilities• Ability to share knowledge and mentor junior engineers on best practices in injection molding for medical devices, fostering a culture of quality and compliance.• Skills in developing training materials and standard operating procedures (SOPs) that align with regulatory and quality requirements
Loading...