Director of Engineering - Cardiac Surgery Systems
Location: Draper Utah
Description: Edwards Lifesciences is at present recruited Director of Engineering - Cardiac Surgery Systems right now, this position will be placed in Utah. Further informations about this position opportunity please give attention to these descriptions. Director of Engineering for the Edwards LifeSciences Cardiac Surgery Systems (CSS) business unit in the Draper, UT facility. This perso! n will be responsible for developing and managing the Manufacturing Engineering strategies for CSS.
Responsibilities:
Direct the engineering activities on all manufacturing production lines to meet production goals, quality and cost objectives
Works closely with production and quality groups to ensure strict compliance with good manufacturing practices guidelines at all times (NCR, CAPA).
Drive Operations Excellence activities within the plant. Lead effective planning for Lean and Six Sigma manufacturing solutions
Support cross functional priorities as needed between Quality, R&D, Regulatory, HR Marketing, Finance, etc and ensure plant compliance with FDA QSR and international ISO standards
Provides development and direction to senior managers and engineering group
Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times
Ability to perform! and assess validations (IQ, OQ, PQ, PPQ, test method validati! ons)
Ensure the organization and team adheres to all company policies, regulations, procedures and business codes of ethics
Qualifications
A Bachelor's degree in engineering is required; a master's degree is preferred
Must be Lean/Six Sigma certified and have a track record of implementing and leading the implementation of operations excellence programs
Must have history of success with IQ, OQ, PQ, PPQ, and test method validation
Extensive experience in process validation
Must have strong leadership skills, and broad managerial capability. Ability to work in a matrix organization and lead cross functional teams
A track record of successfully maintaining and mentoring highly educated, skilled engineers in an entrepreneurial environment
Proven supervisory capability
Proven ability to bring to production Class I, II and III medical devices that meet the strategic plans of the company
!
Experience in new product introductions
Experience with Design for Manufacturability (DFM) process
Proven ability to manage multiple projects and engineering teams
Proven ability to consistently generate and implement innovative and unique solutions to complex technical problems
Good communication and interpersonal skills to work effectively with all levels of employees, vendors, industry personnel
About Edwards
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 8,000 individuals wor! ldwide.
For us, helping patients is not a slogan - it's our li! fe's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
Job Function
:
Engineering - Manufacturing
Primary Location
:
USA-Utah - Draper
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If you were eligible to this position, please email us your resume, with salary requirements and a resume to Edwards Lifesciences.
If you interested on this position just click on the Apply button, you will be redirected to the official website
This position starts available on: Fri, 26 Apr 2013 02:38:22 GMT
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