Under guidance, provide centerline spacing lay out for experimental molds, commercial molds, MTDs and devices
Under guidance, provide designs for experimental molds, commercial molds, MTDs and devices
Manage and control Seals designs and drawings
Manage and control Article designs and drawings
Coordinate tooling orders for manufacturing plants
Support West plants and other engineering departments with basic tooling questions
Assume responsibility for various assigned projects to improve product quality and tooling designs
Collaborate with our fabrication shops and elastomer manufacturing facilities to verify, optimize and correct tooling designs and modifications
Work with cross-functional teams throughout all West locations to develop best practice standards
Maintain awareness of new technology trends, materials, and design/analytical software
Follow FDA, cGMP, ISO, and other applicable regulations
Perform all other duties as directed
Other duties as assigned
Education
Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, or equivalent experience required
Work Experience
No min required 0 - 2 years of relevant work experience required
Prior manufacturing experience in an industrial setting (pharmaceutical industry experience preferred) required
Experience with using SolidWorks and AutoCAD required
Preferred Knowledge, Skills and Abilities
Must have excellent organizational interpersonal and problem-solving skills and be able to interface with employees in all levels of the organization
Excellent computer skills required including all MS Office applications
Effective personal time management skills
Ability to quickly adapt to changes in a dynamic environment
Must be able to negotiate and effectively resolve conflicts when required
Must be able to speak English fluently
Good understanding in machining and fabrication equipment and methods (e.g. milling, turning, grinding, eroding, etc.).
Familiar with cGMP, ISO, and FDA standards.
Familiar with AutoCAD, Finite Element Analysis, Computational Fluid Dynamics, and PDM Pro.
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Able to comply with the company’s safety policy at all times
License and Certifications
Higher National Certificate in Engineering Discipline. Upon Hire preferred
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
Support and contribute in Lean Sigma programs and activities towards delivery of the set target
According to the principles of health and safety at work (substantiated by the Safety Leadership Statement), the job holder is aware of his/her particular responsibility regarding work safety and acts accordingly at all times
The job holder is aware of his/her special responsibility for quality according to the company’s quality policy and conducts his/her activities in accordance with the company quality policy at all times.
The job holder respects all specifications arising from the cGMP requirements and from the specifications DIN ISO 15378 and DIN EN ISO 9001 as per its current state and also as it applies to any future amendments. Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
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