Plymouth Categories:
Principal Design Quality Assurance Engineer superDimension
THIS JOB HAS EXPIRED
Department or Division: RA/QAReports to: Vice President, RA/QA
Summary Statement
The overall job of the Principal Design Quality Engineer is engineering support which leads to the development and introduction into production of new products. They may be responsible for: a) participation in medical device product safety risk management, product reliability measurement, analysis and testing b) creating reliability test fixtures, executing reliability tests in reliability test lab environments c) functioning as a member of cross functional teams by providing technical expertise for projects or subprojects.
Position Responsibilities
Test Engineering Support
Designs and develops test engineering solutions and test systems which would be used to support product validation and verification
Develops engineering test tools and solutions for integrated systems
Develops and writes requirement specifications for test development work activities
Evaluation and research of state-of-the-art test engineering technology
May lead technical teams and/or coordinate the activities of test engineering service providers in the design and development of product test systems
Development Quality Engineering
Supports the planning and execution of design reviews
Supports the designs parts of prototype systems for new products/processes
Develops the sterilization validation route and the biocompatibility materials testing protocols
Ability to supervise and prepare laboratory technician tasks and projects as required
Instructs engineers and technical support staff on engineering test and build requirements
Develops design assurance specifications and test methods
General Quality Engineering
Performs engineering measurements and analysis
Responsible for applying statistical techniques to verification/validation activities and in the area of process controls
Provides support for customer complaint / vigilance process
Develops the risk management file
Assures compliance with company Standard Operating Procedures and policies
Demonstrates knowledge and understanding of standards and guidance relevant to the medical device industry
Stays informed about applicable new rules, regulations, and standards
Qualifications
Development of strategic plans
Executes tactical implementation of strategic plans
Participates in team decision making
Records work in laboratory notebook or equivalent electronic format
Contributes to and executes engineering schedules and plans
Helps prepare cost and time estimates for engineering and project schedules
Provides written reports and engineering documentation as necessary
Provides cost and activity accounting period reports as necessary
Maintains a clean, safe, and orderly work area
Follows all safety procedures
Develops team problem solving and communication skills
Demonstrates skill in the use and care of all tools and equipment
7 plus years of applied technical experience preferably with reliability engineering experience in medical device development. Strong technical and mathematical aptitude.
Education
BS in a science, engineering discipline
| Location: | Plymouth, MN United States |
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THIS JOB HAS EXPIRED
superDimension
Investors: Gemini Israel Funds, Oxford Bioscience Partners, Pfizer Strategic Investments Group, Pitango Venture CapitalAll Jobs: at superDimension
| Web Site: | www.superdimension.com |
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| Headquarters: | 161 Cheshire Lane Suite 100 Minneapolis, 55541 United States |
| Industry: | Medical Devices and Equipment |
