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Validation Engineer -- DP (Urgent)

Company: Infotree Service Inc
Location: tempe
Posted on: May 3, 2021

Job Description:

Job DescriptionThis position supports process management for existing legacy products and risk management.This position is part of the R Product Engineering Team (MDR Project) whose responsibility is to support the EU MDR project timeline, including product remediation testing and label changes.Responsibilities: Leads development of risk assessments and test methods Supports component qualifications, design validation / verification and process validation Ability to make and present risked based decisions Assess process changes against process risk documents Supports translation of design inputs into manufacturing control plans Participate and provide input to training on department/division procedures, and policies. Participate in project planning, budgeting, scheduling and tracking. Develop and implement procedures to comply with corporate and industry standards. Provide positive example and actively promote compliance to division, corporate and industry standards. Maintain a professional working relationship with internal and external customer and support staff. Prepare and present project updates and technical discussions. Working knowledge of product use to manage user(s) impact with the ability to manage risk effectively. Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.) Working knowledge in some of the related business technologies. Advanced statistical and risk assessment techniques. Working knowledge of test method (development and validation), equipment qualifications, and design validation, risk assessment techniques, and component qualification methodologies. Ability to write protocols for Gage R/ MSA studies, perform those studies and analyze results preferably using Minitab Working knowledge of blueprints, and GD Working knowledge of code level review, software logic review, black box testing, and system validation. Ability to make and present risk-based decisions Strong interpersonal skills Ability to analyze and optimize manufacturing and quality systems Product, design & prototyping Ability to create and provide training Software application skills Problem solving ability Ability to create, review and coordinate test protocols and reports Ability to generate engineering proposals Oral and written presentation skills Ability to Lead cross functional teams Understanding of regulatory requirements Ability to create and/or update process mode failure effects analysis (pFMEA) and other related risk documents.Required Qualifications: Strong interpersonal skills Ability to analyze and optimize manufacturing and quality systems Product, design & prototyping Ability to create and provide training Software application skills Problem solving ability Ability to create, review and coordinate test protocols and reports Ability to generate engineering proposals Oral and written presentation skills Ability to lead cross functional teams Understanding of regulatory requirements Ability to create and/or update process mode failure effects analysis (pFMEA) and other related risk documents.Preferred Qualifications: 3-5 years (Master's degree plus zero to three years) of engineering or Quality engineering experience within the medical device or equivalent industry. Lean or Six Sigma Certified (Green or Black Belt) preferred.** Please share the copy of resume at [email protected] **Additional Information.Must be on-site and US Citizen

Keywords: Infotree Service Inc, Tempe , Validation Engineer -- DP (Urgent), Other , tempe, Arizona

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