Provide leadership defining the strategy in support of long-term and intermediate goals within Global Process Development in collaboration within the Global Contract Manufacturing and Technology Network.
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.
Use strong analytical skills to understand and implement customer/user needs, market requirements and other design inputs.
Support CM Sales team in all new business quoting and gathering customer requirements relating to Process Engineering requirements.
Identify, execute, and implement process improvement initiatives across the Global platform.
Provide leadership/guidance on the installation and validation of new equipment/process development through SAT/IQ/OQ/PQ.
Ensure that the procedures and systems are in place to facilitate the introduction of new processes and equipment.
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
Additional Responsibilities
Provide continuity for the validation program for assigned plant or functional area by preparing technical documentation/presentations. Provide project leadership for materials / process related projects by coordinating the efforts of the various departmental disciplines for the successful completion according to plan and budget
Managing internal and external resources to meet the technical requirements of the project, such as outside vendors, and management of techs and/or interns
Work with Tooling 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
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 or another scientific area or equivalent experience required. Preferred Plastics
Master's Degree in Engineering or another scientific area preferred
Work Experience
Minimum 8 years in a similar position within the manufacturing industry required
3 years` experience in leading multifunctional teams of professionals globally required
Good knowledge of LEAN and 6 sigma manufacturing principles (Green belt) required
Good know-how and experience in Project management required
Regulatory compliance in cGMP manufacturing and testing of Pharmaceutical or Medical Device Products.
Ability to manage projects, teams, maintain timelines, and execute projects in a Global Engineering environment
Preferred Knowledge, Skills and Abilities
Expertise in injection molding techniques, methodology, and trouble-shooting methods; a deep understanding of equipment, process, and tools relating to injection molding
Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
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.
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
Support and contribute to Lean Sigma programs and activities towards delivery of the set target
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.
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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
Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
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