Overall Job Summary: This position supports several R&D activities related to the development and design of disposable medical device products. The primary focus will be leading quality efforts in developing or reviewing:
* Consumable design verification and validations
* Steam sterilization/cleaning validations of re-usable products
• Sterile packaging design and shelf life validations
• R&D development plans, design reviews
• Supporting project teams with technical counsel, training on standards and SOPs Ideal candidate will possess:
• Ability to logically evaluate and critique technical documents and assist teams in making thoughtful balanced decisions
• Solid understanding of single use product development (e.g. sterile packaging, sterilization, etc.) including familiarity with EN ISO 11607-1 & -2; AAMI TIR’s 12, 28, & 30; and the EN ISO 10993 biocompatibility series.
• Strong capability to focus attention on details
• Ability to prepare clearly written and highly detailed technical documents, procedures, job aids, and the occasional PowerPoint presentation
• General knowledge of common device fabrication and inspection processes (molding, extrusion, metrology, etc.)
• Basic knowledge of applied statistics (equivalent to ASQ CQE level)
The candidate will have a BS Degree in biology and/or engineering, and experience in supporting the development of new disposable medical devices. This experience should include five or more years in validating, testing, and supporting development of consumable medical devices. Specific experience in validating steam sterilization cycles to industry standards is helpful. Must have effective written and verbal communication skills, be detail-oriented, and possess strong interpersonal skills.
Job Type:
Permanent
Location:
California-Central Coast
Salary:
[n/a]
Date available:
now
Experience Skills:
Qualified
Company:
Alcon Laboratories
Company Description:
We challenge ourselves to meet Alcon's mission every day to enhance, preserve and restore vision worldwide. Alcon employees, around the globe, go a step beyond that mission and dedicate themselves to making Alcon the most respected and trusted eye care company in the world. We know we are earning our position as the first choice in eye care products every day through hard work and dedication we never take that for granted.
Company Website:
[n/a]
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08/12/2009