Position Responsibilities: ·
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.
Position Requirements: · 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.