POSITION SUMMARYThe Principal Injection Molding Engineer is responsible for leading and coordinating the process development activities to support new product developments, sustaining engineering efforts, including cost reductions and design / manufacturing for injection molded components.
The role will be a critical liaison between the Research and Development functions and Manufacturing.
- PRINCIPAL RESPONSIBILITIES :
- Plans and leads process development activities including design, prototyping, testing (verification and validation) risk management / process FMEA, process characterization, and documentation.
Participate in the redesign of existing processes to improve quality, utilize automated production techniques, optimize process capabilities, and product improvements in a more cost-effective manner.
Drives quality improvements by risk assessment / mitigation eliminating sources of defects in the design, new product introduction and manufacturing processes.Lead upfront mold design simulation to ensure robust mold design and build coupled with right first-time validationProvide technical expertise in developing new tooling, guidance in processing and troubleshooting.Approve new tooling designs to ensure they are consistent with the product design
Evaluate and implement globally advanced molding technologies such as multi-shot, insert molding, and micro-molding.Drive innovation in tooling design to support appropriate cavitation and complex geometries while adopting the latest technology in injection moldingInterface with product development and manufacturing to understand product requirements and establish design criteria for manufacturing processes.Define and optimize molding parameters using scientific molding principles.
Interact with suppliers to define and evaluate materials and processes needed for effective execution of process development activities.Advise and mentor other engineering personnel on technical aspects of product / process design, molding techniques and the validation of processes.Working with project management, ensure all components / documents are properly placed into SAP and AgileEDUCATION / EXPERIENCE REQUIREMENTS :Bachelor in Engineering required with Masters or PhD in Plastics Molding preferredExperience in Molding Process and Tooling DevelopmentAt least 15 years minimum of experience in injection molding with molds Design preferably within a medical device companyMaster Molding & Parts & Molds Design Certifications PreferredFluent in EnglishExperience with introducing new mold components within the medical device field.Deep understanding of scientific molding, mold simulation, melt flow analysis and decoupled molding techniques
Process capability studies, DOE (Design of Experiments), and root cause analysis.Excellent communication, presentation and multi-functional departmental leadershipAn understanding of ISO, GMP and FDA regulationsSPECIALIZED SKILLS & OTHER REQUIREMENTS :Must be a well-organized self-starter with attention to detail, and ability to follow written & verbal instruction, take initiativeStrong analytical and problem-solving skills and comprehensive understanding of design control processes and validation of processes and designs.Effective verbal, presentation and written communication skills.Excellent interpersonal skills with demonstrated leadership, organizational influence and decision making competencies.Adept at CAD ideally SolidworksGeometric Dimensioning and Tolerancing (GD&T)Statistical tools (SPC, Gage R&R, DOE)Working knowledge of medical device development, medical device regulations.MS Office (Word, Excel, Access, PowerPoint).TRAVEL REQUIRED : 25 % Approx.