Role & responsibilities The role in one paragraph

We need someone to own how products get built. That means taking a device from a working prototype through design-for-manufacture, vendor selection, tooling, pilot build and into repeatable volume production and deciding, product by product, whether it should be made in-house or placed with a contract manufacturer. Some of our line will need in-house manufacturing; some is better contracted out.

The judgement about which is which, and the discipline to make either route hold quality, is the core of this job.

What you will do

- Own the prototype-to-production pathway for products coming out of R&D; design for manufacture and assembly, process definition, tooling and fixture specification, pilot lots, first-article inspection and production sign-off.
- Make and defend the in-house versus outsourced decision for each product and each major sub-assembly, with the cost, volume, quality-risk and IP reasoning written down.
- Identify, evaluate, qualify and manage vendors and contract manufacturers capability audits, build-to-print quotations, first-article dimensional reports, process qualification and ongoing performance management.
- Set up and run the quality system on the shop floor to medical-device standard inspection plans, traceability and device history records, non-conformance and CAPA, and the test evidence our products are required to carry.




- Own manufacturing cost. Drive COGS down through design, sourcing and process, and give the leadership team a costing they can rely on.
- Plan and hold production schedules against committed customer deliveries, including institutional orders with hard deadlines.
- Recruit, train and lead a small manufacturing and quality team, and build the function as volume grows.

Strongly preferred:

- Medical device manufacturing experience and familiarity with ISO 13485; awareness of CDSCO requirements and of product-specific standards such as ISO 7176 for wheelchairs.
- Experience with welded tubular structures, precision fabrication, sheet metal, machining and surface finishing
- Experience with mechatronic or electromechanical assemblies — motors, drives, sensors, embedded electronics, cable management and functional end-of-line test.
- Experience setting up a new facility or a new production line from scratch.
- Exposure to a startup or a small-team workplace where you owned the outcome end to end.

How we will assess this The interview process includes a working session in which you walk our technical team through a product you personally took from prototype to production — the decisions you made, what went wrong, and what you would do differently. We also discuss a live sourcing scenario. We are testing judgement, not recall.

📌 Manufacturing Lead (Chennai)
🏢 Entry2Entire Solutions
📍 Chennai