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Sustaining Engineer

LanceSoft Inc.
Acton, Massachusetts, 01720, United States
June 10, 2019


Job title: Sustaining Engineer

Location: Acton, MA


• Serve as Project Manager and Design Engineer for multiple cost savings project

• Establish project timeline

• Coordinate sample builds and conditioning

• 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.)

• Presents project progress to Senior Management

• Perform other tasks or projects as assigned

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)

Description : 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