We are looking for a Mechanical Engineer to join our client in Cambridge, Ma on a contract to hire basis.
· Take the lead mechanical role on multiple projects, coordinate engineering resources and act as a point contact for clients.
· Personally execute mechanical design activities as required (CAD, engineering analysis, documentation).
· Drive engineering excellence in all aspects of our service.
· Work effectively with multi-disciplinary design teams to ensure integration of all stakeholder inputs.
· Think creatively and analytically to develop comprehensive design solutions.
· Understand project requirements, anticipate development challenges and manage engineering resources to deliverable robust solutions on schedule and budget.
· Manage regulatory documentation in compliance with quality system and industry standards.
· Adhere to disciplined design process using design controls, FMEA, rapid prototyping and design reviews.
· Work with management to prepare project plans and coordinate project management activities.
· B.S. in Mechanical Engineering. Advanced technical degree is desirable.
· 10+ years practicing mechanical design with significant combination drug delivery device experience.
· Experience working through at least 3 complete concept-to-manufacturing development cycles.
· Strong experience working in compliance with ISO13485 and FDA QSR.
· Strong technical and analytical skills including FEA and CFD.
· Experience with all major production processes, including plastic and metal fabrication methods.
· Electro-mechanical design experience – motors, actuators, drive trains, bearings
· CAD Skills - Advanced surfacing and master model strategy using Solidworks and Pro Engineer.
· Excellent interpersonal, communication and leadership skills.
· Personal commitment to quality, customer service and creative design solutions.