New Product Development – Manager
- Managing one or more manufacturing processes
- Assisting with planning and directing the layout of equipment
- Ensuring production follows appropriate workflow and assembly methods
- Ensuring Manufacturing performance and Quality goals are met
- Apply engineering skills, in a collaborative team, to perform sustaining engineering tasks for released products.
- Understand and interpret schematics, component data sheets, and mechanical engineering drawings.
- Prepare and review documentation to support design history files (DHFs). Prepare production assembly instructions, and production testing procedures in accordance with ISO13485 standards.
- 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.
- Conduct failure mode & risk analysis of medical devices according to ISO 13485 and international requirements.
- Travel to contract manufacturer and suppliers as needed to support product manufacturing. Participate as technical representative in vendor audits.
- Assure the timely manufacturing, packaging, and delivery of new products
- Identify, source, and implement improvements in manufacturing procedures
- Work with quality team to drive component issues upstream to suppliers. Use continuous improvement process in yield and quality/reliability programs
- Coordinate relationships with vendors and contractors.
- Support and conduct validation studies, technology transfer activities, process characterization studies, and gauge R&R studies within the Manufacturing Process. Provide guidance on the equipment/process validation requirements and design control activities for new product development projects.
- Evaluate the underlying issues and offering long-term solutions. This includes completion of required CAPA processes. Document and implement system improvements.
- 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.
- Support manufacturing transfers to alternate suppliers.
- Masters in Bio-engineering/engineering preferred
Knowledge and Training
- Demonstrated strong technical and analytical/problem solving skills
- Experience with engineering change orders, documentation needs, protocol and report writing.
- 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 Supplier Quality Systems processes.
- Ability to assess the feasibility of process modifications to improve manufacturing quality and throughput.
- Strong interpersonal and collaborative skills. Works well as a supportive team member.
- Experience using Solid Works mechanical CAD tool is desirable.
- Contact Person: Ms. Meenu.
- Contact Number: +91 9560043049.
- Email ID: firstname.lastname@example.org
Job Category: Product Development
Job Location: Gurugram