Title:  Principal Molding Engineer

Job Summary

Support the Global Process Engineering Injection Molding group by evaluating and implementing new equipment through validations and involvement in process improvement projects. Solve demanding and ‘impossible’ problems with a combination of engineering expertise, practical know-how and a willingness to reach outside of existing knowledge areas to identify novel solutions.  Carry out special analytical investigations to generate critical technical information, making decisions concerning product improvement and overall quality.  Implement, interpret, correlate, and communicate statistical studies performed on manufacturing processes. Through understanding of tooling / process interactions and development of process, provide all pertinent validations of both tooling and process.  Interacts with Engineering / Customers on new projects or issues pertaining to the facility’s processes.  Write detailed technical reports on analytical data; provides periodic updates pertaining to assigned projects.

Essential Duties and Responsibilities

• Take a lead role in West’s early conceptual Injection Molding development process
• Use strong analytical skills to understand and implement customer/user needs, market requirements and other design inputs.
• Develop scope of work, plan and manage for Injection Molding/Equipment Validation projects for the introduction of all new products into the company and compiling standard specifications for each process and monitoring all existing production to standard specifications.
• Lead the installation and validation of new equipment/process development through SAT/IQ/OQ/PQ.
• Translate product requirements into device specifications
• Drive idea creation, development, bread boarding/prototyping, feasibility testing, etc. to evaluate viability of ideas.
• Lead and advise component material selection with a strong emphasis on polymer selection for injection molded parts.
• Hands-on engineering, such as reverse engineering, simple assembly and machining work, component testing and failure analysis
• Provide continuity for the validation program for assigned plant or functional area by writing validation documentation Provide project leadership for materials / process / Tooling related projects by coordinating the efforts of the various departmental disciplines for the successful completion according to plan and budget
• Create engineering change requests for modifications to equipment and the introduction of new equipment/molds
• Managing internal and external resources to meet the technical requirements of the project, such as outside vendors, and management of techs and/or interns
• Prepare detailed technical reports and design documentation in compliance with the Innovation Group’s internal development process
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Additional Responsibilities

• Work with Industrial Design team to plan innovative technical approaches to design solutions
• Coordinate engineering meetings with manufacturing plants. Identify, monitor status of results or projects.
• Leveraging internal and external resources to solving complex problems
• Managing of projects using good engineering principles and techniques
• Support the management of external engineering and design resources with appropriate interaction with their technical teams
• Help execute specific strategies, tactics and action plans for the location, as part of the overall Delivery Systems/Innovation product development plan, inclusive of management/ tracking of project activities and resources

Education

• Bachelor's Degree in Engineering. Plastics required.

Work Experience

• Experience: 8-10 years of experience
• Regulatory compliance in cGMP manufacturing and testing of Pharmaceutical or Medical Device Products.

Preferred Knowledge, Skills and Abilities

• Excellent written and verbal communication skills
• Experience working with teams and influencing decisions
• Must have an in-depth knowledge of Statistical Process Control (SPC) and Design of experiments (DOE) and demonstrate use of same.
• Should have a good knowledge of the principles of WCM, JIT, SMED, and Kaizen
• Excellent understand of the Scientific approach to Injection Molding
• Preferred understanding of EDARTS, RJG Master Molder certificate
• Must have knowledge in computer systems; integrated manufacturing systems; word processing and spreadsheets
• Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
• Must be able to deal with all levels of employees and work across various departments.
• Experience in writing and executing validation protocols and reports,
  • Ability to function as a team member

License and Certifications

Travel Requirements

Physical Requirements

Additional Requirements

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems