Mechanical Engineer

5 - 9 years

5 - 10 Lacs

Posted:4 hours ago| Platform: Naukri logo

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Work Mode

Hybrid

Job Type

Full Time

Job Description

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)

How to apply for this opportunity?

Easy 3 Step Process:

  • Click On Apply and register or log in to our portal
  • Upload updated Resume & complete the Screening Form
  • Increase your chances of getting shortlisted & meet the client for the Interview!

About Uplers:

Our goal is to make hiring and getting hired reliable, simple, and fast. Our role will be to help all our talents find and apply for relevant product and engineering job opportunities and progress in their career.

(Note: There are many more opportunities apart from this on the portal.)

So, if you are ready for a new challenge, a great work environment, and an opportunity to take your career to the next level, don't hesitate to apply today. We are waiting for you!

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