- Responsibilities
- New product design & development initial stage to production stage.
- Benchmarking of the product.
- Test and record performance of components, products & manufacturing methods.
- Analyze and resolve technical issues associated with components, products, manufacturing methods and performance.
- Prepare bill of materials (BOM), design specifications & raw materials specifications etc.
- Conduct failure mode & risk analysis according to ISO 13485.
- Responsible for product design verification & validation and maintain its records.
- Ensuring Manufacturing performance and Quality goals are met.
- Prepare and review documentation history files (DHFs). .
- Maintain and improve existing product manufacturing processes. Anticipate Manufacturing’s need for new products and fixtures.
- To be involved in the assembly, troubleshooting, testing, and repair activities of our products.
- Provide instruction and support to Manufacturing and QA on manufacturing techniques, procedures, and QC inspections.
- Survey and identify replacement components for reasons of obsolescence or cost reduction.
- Identify and contact vendors. Compare technical specifications. Compile and prepare required documentation.
- Assure the timely manufacturing, packaging, and delivery of new products.
- Identify, source, and implement improvements in manufacturing procedures.




- Coordinate relationships with vendors and contractors.
- Responsible for on-going process improvement: take initiative to define, plan, and execute improvement projects, achieve objectives in increasing yields, reducing cycle time, reducing overall cost, and improving product quality and reliability.

Education

- Butcher of Engineering or Equivalent

Experience

- Required minimum 5 year experience in medical device industries.

Knowledge and Training

- Solid knowledge of medical devices product design and development process.
- Knowledge of injection multi cavity injection mould, die, fixture and machine design.
- Knowledge of design and drawing change control procedure.
- Ability to assess the feasibility of design modifications to existing designs.
- Experienced in troubleshooting and recommending corrective or preventive actions to improve product reliability.
- Experienced in interfacing with functional groups outside of engineering
- Good communication skills, verbal and written
- Knowledge of ISO 13485 / MDR 2017
- Strong interpersonal and collaborative skills. Works well as a supportive team member.
- Knowledge of CAD software Solid Works is desirable.

Contact Person: Mr. Amit Kumar
Contact Number: +91-XXXXXXXXXX.
Email ID: [email protected]

Job Category: Product Development

Job Location: Gurugram

📌 New Product Development – Manager (India)
🏢 Mais India Medical Devices
📍 India