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).
• 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 internal 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.
Engineer In Training
Engineering Design Process