Experience
: 5.00 + years
Salary
: Confidential (based on experience)
Shift
: (GMT+05:30) Asia/Kolkata (IST)
Opportunity Type
: Hybrid (Chennai)
Placement Type
: Full time Permanent Position
(*Note: This is a requirement for one of Uplers' client - Aletha Health)What do you need for this opportunity?Must have skills required:Plastic Injection Molding, Plastic Design, Plastic Molding, Quality Control, Quality Assurance, DFM, DFAAletha Health is Looking for:
Role Summary
Own the end-to-end development, validation, and scaling of plastic components for medical devices. You’ll 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 theirmanufacturing 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, IndiaReporting to: Head of Manufacturing / Operations (or equivalent)
How to apply for this opportunity?
- Step 1: Click On Apply! And Register or Login on our portal.
- Step 2: Complete the Screening Form & Upload updated Resume
- Step 3: Increase your chances to get shortlisted & meet the client for the Interview!
About Uplers:
Our goal is to make hiring reliable, simple, and fast. Our role will be to help all our talents find and apply for relevant contractual onsite opportunities and progress in their career. We will support any grievances or challenges you may face during the engagement.(Note: There are many more opportunities apart from this on the portal. Depending on the assessments you clear, you can apply for them as well).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!
