West Pharma Principal Tooling Engr NA 

United States, California, Santa Cruz 

424296063

Reporting to the Senior Manager for Global Tooling, the Principal Tooling Engineer will be responsible for supporting the execution of various tooling engineering projects relating to medical device & contract manufacturing within West. The role will support the implementation of the Tooling Engineering strategy within Global Engineering whilst ensuring the commissioning, qualification and validation of tooling equipment, processes and procedures are carried out in accordance with GMP and relevant guidelines.

The Principal Tooling Engineer will liaise with customers and suppliers in the support of tooling development, refurbishment and replacement for new and existing global programs. Responsibilities will include managing vendor selection, conceptual design, selection of hot runner system, project management of tool fabrication and implementation into manufacturing. This role will support the harmonization of tooling/process principles, practices, and procedures across Global Tooling Engineering. The Principal Tooling Engineer will demonstrate excellent attention to detail and manage their time efficiently.

• Responsible for the project management of various internal and external highly skilled technical resources in providing tool design and manufacturing support.
• Manage and lead as work package owners, complex tooling projects from conception through qualification.
  • Manage tooling suppliers on request for quotation (RFQ), mold design reviews, hot runner system selection, schedules, mold factory acceptance test (FAT) and project implementation at site.
  • Manage product and tool design reviews to ensure they are designed for manufacture and efficiency and are conducted in accordance with West CM mold design guidelines and build standards.
• Provide expert knowledge in part design for manufacturability using Mold Flow Analysis to evaluate mold filling, mold cooling and warpage analysis, to ensure a robust tool design.
• Successful management and delivery of tooling projects to agreed time scale and budget.
• Ensure suppliers meet customer and West tooling needs.
• Manage the successful handover of new validated tooling into production by liaising with customers, suppliers and internal West teams.
• When required, support investigations and root cause analyses of major tooling issues.
• Compile and deliver reports from critical tooling information gathered.
• Establish strong relationships with customers and suppliers in pursuit of continuous tooling improvements and on-going business development.
• Work closely with Finance, Program Managers and commercial teams to ensure visibility on engineering revenue forecasts and timely invoicing takes place.

• Analyze the current Tooling supply chain, identifying new suppliers to source technologies for demanding technical applications.
• Assist with the harmonization and implementation of Tooling Engineering standards and procedures across the CM Device Manufacturing Network based on current regulations, industry standards and industry practices permitting agility to meet the future needs of the business.
• Identify and implement continuous tooling improvements for future/repeat molds.
• Manage the control of tool documentation, drawing and file management.
• Develop, review and revise tooling validation documentation.
• Attend internal meetings to establish priorities
• Liaise with external suppliers on the repair/replacement of tooling components and equipment
• Research and implement improvements to processes and procedures.
• Work autonomously within established procedures and practices.
• Comply to West Environmental, Health and Safety requirements, training and regulations
• Comply to all West company policies, procedures and corporate policies
• Act in accordance with West’s Guiding Principles and adheres to the Corporate Code of Conduct.
• Report/escalate all issues to Senior Manager, Global Tooling.
• Perform additional duties at the request of the Senior Manager.

• Engineering degree in Tool Design or related field preferably with practical experience working with injection molds.

• Minimum 8 years of experience in the design, manufacture and project management of multi-cavity injection molds.
• Extensive practical experience in Computer Aided Design, with proficiency in 3D modelling software packages, eg. SolidWorks.
• Advanced and specialized tooling expertise, typically developed through a combination of job-related training and considerable on-the-job experience
• Demonstrate an in-depth knowledge of Statistical Process Control (SPC) and Design Of Experiments (DOE) within the Medtech industry
• Practical working knowledge and understanding of X Ray Computed Tomography (CT scanning) and 3D surface analysis using this technology.
• Relevant experience in a cGMP regulated industry.
• Proven track record on ensuring compliance to quality requirements in a medical device manufacturing environment
• Ability to work under pressure
• Must be able to organize and prioritize tasks for self
• Ability to build strong business relationships with all stakeholders

• Understand all relevant standard operating procedures as per Company policy as related to this position.
• Excellent written and verbal communication skills with the ability to accurately document work performed.
• Effective analytical and problem-solving abilities
• Knowledge of tooling servos, hydraulics, pneumatics and electrics
• Proficient IT skills, specifically Microsoft Office (Word, Excel, PowerPoint, Project and Outlook)