New Product Development – Manager

Responsibilities

  • 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.

Education

  • 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: hr@maisindia.com
Job Category: Product Development
Job Location: Gurugram

Apply for this position

Allowed Type(s): .pdf, .doc, .docx

Start typing and press Enter to search

Need Help?