Medical Device Support Engineer (ECO's/ECP's, design changes, Configuration Control) Job in framingham 01702, Massachusetts US
We are currently looking for a Medical Device Support Engineer with a strong background in design, documentation, ECO's/ECP's in Framingham, MA .
This is a long-term contract in Framingham, MA, please email your resume to Todd.Schecter [at] AdeccoNA [dot] com for consideration.
Roles and Responsibilities: *5-10 years experience in configuration control in a FDA design/manufacturing environment, with specific experience in the planning and conduct of physical configuration audits.
*Strong applied knowledge in project management, Configuration Management and document management.
*Knowledge of Configuration Management methodology, concepts and workflow.
*Experience with FDA specification practices and knowledge of industry design/drawing practices * Knowledge of FDA 21 CFR Part 820 required.
* Change management processes, and Engineering Change Order/Proposal (ECO/ECP).
*Responsible for all hardware and software CM functions to include the control of documentation within projects.
Maintains and controls engineering drawings.
* Maintains various program CM baselines, Identification, Configuration Control, Configuration Status Accounting (CSA), and Configuration Audit.
*Coordinate with relevant project personnel to facilitate obtaining all changes and deliverables for each Project.
*Control and track changes to Product Baselines including software, hardware, documentation and drawings from project inception to project closeout.
*Aids in the development of the Configuration Management disciplines required to manage a program.
*Conceives and develops Configuration Management policies and procedures as needed.
Requirements: Bachelor of Science degree plus 8-10 years of directly related experience.
SAP Implementation experience is a plus, Medical Device experience required Must be self-motivated, team player, proactive, and require minimal supervision.
Apply Online
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