Our client, a medical device manufacturer in the Acton, MA area has an immediate need for a Project Engineer for a 7+ month contract position.
Serve as Project Manager and Design Engineer for multiple cost savings project
o Establish project timeline
o Coordinate sample builds and conditioning
o Hold regular team meetings assuring that project timing and budget are on track
Understands and follows all internal policies and procedures related to area of responsibility including design control, testing, and document control
Applies current Medical Device Industry standards to existing products (ex. Risk Management, Human Factors Engineering, Biological Assessments, Product Performance Testing, etc.)
SKILLS, KNOWLEDGE AND EXPERIENCE REQUIRED:
Project Management able to effectively manage and complete multiple projects, and project teams, simultaneously
Project Management able to create and manage a project schedules and keep spending to approved budgets
Full working understanding of FDA CFR 820 and ISO 13485 regulations, and how to develop products within the requirements.
Understanding of Injection Molding processes and qualification of injection molded finished products.
Able to build stable internal and external working relationships
Ability for detail orientation and accuracy when completing documentation and written communications
Experience in 3D modeling with SolidWorks and Solid Edge (optional)
EDUCATION and/or EXPERIENCE:
Bachelor of Science Degree in Mechanical Engineering or closely related 4 year Technical degree with 3-years of relevant work experience
Regulated industry experience that includes FDA and ISO requirements is a plus
Presents project progress to Senior Management
Perform other tasks or projects as assigned