Mechanical Engineer

Plastic Manufacturing Engineer (Medical Devices)

Experience:

Opportunity Type:

Placement Type:

Note: This is a requirement for one of Uplers' Clients Aletha Health:

Must have skills:

About Aletha Health:

Aletha Health is dedicated to freeing individuals from pain caused by muscle tension through innovative, drug-free solutions. Our products offer effective alternatives to medication and invasive procedures, empowering users to achieve a pain-free life with simplicity and confidence.

Role summary

Own the end-to-end development, validation, and scaling of plastic components for medical devices. Youll convert design intent into robust, cost-effective manufacturing at suppliers, lead tooling/process validation, and mentor interns and junior engineers—partnering closely with Design, Quality, and Supply Chain.

Added advantages: Medtech device startup experience; strong DFM/DFA and GD&T skills; deep knowledge of plastics materials science, including biocompatible materials and their manufacturing processes.

Key responsibilities

• DFM/DFA for plastic parts: drive draft/rib/wall strategy, gate/parting/ejector
• considerations, knit-line/warpage control, tolerance stack-ups, and release to manufacturing.
• Tooling & process development: lead mold design reviews (runner, gating, cooling, venting), T0/T1 trials, DOE-based optimization; experience with over-molding/insert molding; exposure to extrusion/blow molding/thermoforming is a plus.
• Validation & quality: plan/execute IQ/OQ/PQ, PFMEA/Control Plans, PPAP/FAI as applicable; establish SPC with Cp/Cpk targets; conduct Gage R&R/MSA.
• Biocompatible materials: select and qualify medical-grade polymers (e.g., PC, ABS, PP, PA, POM, TPU/TPE, PEEK/PEI where relevant) considering ISO 10993/USP
• Class VI, sterilization compatibility (EtO, gamma, e-beam, autoclave), and aging/performance trade-offs.
• Regulatory alignment: collaborate with Quality/Regulatory to meet ISO 13485 QMS, ISO 14971 risk management, and FDA 21 CFR 820 / EU MDR documentation expectations (DHF/DHR, traceability, change control).
• Supplier/Vendor management: identify and develop suppliers, negotiate tooling, run process trials, perform audits, and drive yield/cycle-time/cost improvements.
• Metrology & troubleshooting: own dimensional inspection (CMM/vision/hand tools); lead structured problem solving (5-Why, Ishikawa, 8D) for defects (short shot, sink, flash, burn, warpage, splay).
• Manufacturing readiness: create work instructions, line layouts, and training; support cleanroom molding/assembly (ISO 14644) when required.
• Mentorship & collaboration: train interns and junior engineers; drive documentation rigor and shop-floor discipline.
• Travel: frequent domestic vendor visits and occasional overseas travel for supplier development and ramp support.

Required qualifications

• Education: B.E./B.Tech in Mechanical, Manufacturing, Plastics/Polymer Engineering (or related). M.E./M.Tech preferred.
• Experience: 5+ years in plastic part manufacturing with strong hands-on injection molding and ownership of tooling/process validation for precision components.
• GD&T: solid command of ASME Y14.5 and tolerance stack analysis.
• Material science: proven experience selecting/processing medical-grade, biocompatible polymers and documenting rationale/verification.
• Validation & stats: DOE, SPC, capability analysis, MSA/Gage R&R proficiency with Minitab (or equivalent).
• CAD/Simulation: SolidWorks/Creo/NX; familiarity with Moldflow/Moldex3D is a plus.
• Quality systems: experience in regulated environments; comfort with design controls, DHF/DHR, CAPA, and change control.
• Mobility: willingness to travel to meet vendors and travel overseas as needed.
• Soft skills: crisp technical writing, vendor negotiation, cross-functional communication, and bias to action on the shop floor.

Job location: Chennai, India

Reporting to: Head of Manufacturing / Operations (or equivalent)

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