Senior / Principal Packaging Engineer

Apply by eMail:do_not_reply@invalidemail.com

Description:
 
At ev3 we’re committed to developing innovative endovascular technologies for peripheral and neurological applications.  Creative, competent people with a passion for enhancing healthcare around the globe have driven our success.  Join us as we grow by making a meaningful difference.    We are currently seeking a Senior or Principal-level Packaging Engineer to work with design teams, implementing packaging design or process changes to improve the quality, performance, safety and cost of the products assigned, fitting in to customer and product requirements.
 
MAIN RESPONSIBILITIES
Develop specific project plans and objectives that allow for rapid continuous improvement.  Execute those plans on time and in accordance with the objectives.
Write manufacturing processes, test procedures and reports.  Assist with the development of both component and final product specifications.
Conduct and document the necessary process validations and production qualifications as required.
Perform project support / management responsibilities as assigned for new products and process changes per ev3’s product development procedures.
Provide work direction and product related training to technicians and assemblers as needed.  Keep the operations management team informed of project activities that affect their areas of responsibility.
Interface with various product development teams to develop packaging and labeling solutions that are cost effective.
Train the production personnel on new processing techniques and ensure they understand the accept/reject criteria.
Design, implement and maintain the assembly equipment and fixtures that support the achievement of our cost and capacity goals.  Work with tooling group and machine shop.
Maintain positive vendor relations through regular communication and rapid problem resolution.
Estimate costs, equipment and personnel needs as they relate to existing and new products.
Justify the expense of major pieces of capital equipment; outline their benefits and document them once the equipment is implemented.
In an effort to achieve “world-class” status, understand, teach and implement JIT, TQM and demand flow principles throughout the operations group and specifically on the assigned products.
Perform job functions and duties in compliance with QSR, ISO and MDD regulations.
Comply with applicable FDA and international regulatory laws/standards and the ev3 Code of Conduct.

BASIC QUALIFICATIONS
 
Bachelor’s degree in Engineering with 7+ years of related experience. 
4+ years’ Medical Device industry experience.
In-depth knowledge of FDA / Regulatory packaging requirements and the ability to apply them.
Diverse packaging product lines: pouches, sealing, trays, corrugated.
 
PREFERRED QUALIFICATIONS
 
Knowledge of QSR, ISO and MDD regulations
 
POSITION REQUIREMENTS
 
Thorough knowledge of materials, processing methods and assembly equipment.
Learnable labeling experience.
Working knowledge of word processing, spreadsheet, database, CAD and statistical software.  Working knowledge of Access a plus.
Mechanical aptitude, the ability to work independently and strong communication skills.
Must be able to travel to Irvine, CA, facility several times per year.
 
We offer competitive compensation, generous benefits, and the opportunity to improve the lives of people everywhere.  For consideration, please apply online at www.ev3.net/careers.
 
No phone calls please. 
 
Equal Opportunity Employer / Affirmative Action Employer
 
 

Apply by eMail:do_not_reply@invalidemail.com

Job Created: Sat Sep 26 2009 05:39:13 AM
Last Modified: Fri Nov 20 2009 07:08:11 AM