Plastic Manufacturing Engineer (Medical Devices)

Role Overview: You will be responsible for owning the end-to-end development, validation, and scaling of plastic components for medical devices. Your role will involve converting design intent into robust, cost-effective manufacturing at suppliers, leading tooling/process validation, and mentoring interns and junior engineers while closely partnering with Design, Quality, and Supply Chain. Key Responsibilities: - Drive DFM/DFA for plastic parts including draft/rib/wall strategy, gate/parting/ejector considerations, knit-line/warpage control, tolerance stack-ups, and release to manufacturing. - Lead tooling & process development by conducting mold design reviews, T0/T1 trials, DOE-based optimization, and experience with over-molding/insert molding. - Plan and execute validation & quality processes such as IQ/OQ/PQ, PFMEA/Control Plans, PPAP/FAI, establish SPC with Cp/Cpk targets, and conduct Gage R&R/MSA. - Select and qualify biocompatible materials, considering ISO 10993/USP Class VI, sterilization compatibility, and aging/performance trade-offs. - Collaborate with Quality/Regulatory for regulatory alignment and meet ISO 13485 QMS, ISO 14971 risk management, and FDA 21 CFR 820 / EU MDR documentation expectations. - Manage suppliers/vendors by identifying and developing suppliers, negotiating tooling, performing audits, and driving yield/cycle-time/cost improvements. - Own dimensional inspection and lead structured problem-solving for defects, support manufacturing readiness, and mentor interns and junior engineers. - Be prepared for frequent domestic vendor visits and occasional overseas travel for supplier development and ramp support. Qualification Required: - B.E./B.Tech in Mechanical, Manufacturing, Plastics/Polymer Engineering (or related). M.E./M.Tech preferred. - 5+ years of experience in plastic part manufacturing with strong hands-on injection molding and ownership of tooling/process validation for precision components. - Solid command of ASME Y14.5 and tolerance stack analysis. - Proven experience in selecting/processing medical-grade, biocompatible polymers and documenting rationale/verification. - Proficiency in DOE, SPC, capability analysis, MSA/Gage R&R, and familiarity with Minitab (or equivalent). - Experience with CAD/Simulation software and quality systems in regulated environments. - Willingness to travel and possess soft skills like technical writing, vendor negotiation, and cross-functional communication. (Note: This job opportunity is for one of Uplers" clients - Aletha Health. Apply through the Uplers portal for this and other similar opportunities available.) If you are ready for a new challenge in a great work environment and wish to take your career to the next level, apply today through the Uplers portal. We look forward to welcoming you!,