Roles & Responsibilities:
Design new engineering products and processes
Craft models and drawings of products using CAD
Analyze prototype data and retest if needed
Improve existing products and processes
Ensure compliance with the industry’s safety standards
Making and maintaining accurate records as per EN ISO 13485
To prepare design file of the product
Find creative design solutions to problems
Initiate Risk Management file during product development planning phase and update with
risks/complaints from competitive models
Communicate team as when changes are made along with approved documents.
Update and communicate team members on information from public data on competitor
models.
Responsible for all design and development related activities
Establish and ensure the project team with representation from Manufacturing, Quality,
Regulatory, service engineering and Marketing for preparing design plan, inputs and design
change activity planning.
To analyze Clinical evaluation report
Participate in review and support team with technical information.
Implement and review CAPA as defined
Responsible for Software development related activities.
Construct project plans
Maintain an in-depth understanding of the projects and related contractual, technical, and
quality documentation.
Maintain the project calendar.
Balance the demands of several simultaneous projects
Schedule project meetings and keep meeting minutes.
Identify, track, manage, and resolve project issues.
Drive change management processes, manage stakeholder expectations, communicate
impact, and execute changes if applicable.
Design and develop new products.
Rectify the design based on customer feedback and after internal analysis.
Collaborate with Quality Department to identify and implement ongoing quality
improvements.
Develop and implement production processes for new products, product enhancements and
product changes. Install related fixtures and tooling, as required.
Source new equipment and material suppliers as required.
Must have hands on experience designing New Product Development based on Customer
need, should be able to develop basic Reverse Engineering & Bench Marking Methodology
Knowledge on Product Simulation, Design, Modelling, Prototype developments / Testing
Concept Planning, Design & Execution
Must have experience of Design Reviews/ Verification / Validations, Risk Analysis, FMEA's,
Control Parameters', Analytical Skills, MSA's,
Setting up the Equipment Validations IQ, OQ & PQ within given timeline.
Knowledge of Material Selection as to support Operations Team
QMS support to comply the standards & Release the Product based on Standards
Understand ISO 13485 is a plus, Preparation of Design history file for each project which
includes documents like Design input, Design output, BOM, Design verification report,
Design validation report, Risk analysis etc.
Engineering Change Order creation is part of the role, providing design enhancements and
kit structure to enable manufacturing.
Participates in the preparation of concept and feasibility studies.
Job Types: Full-time, Permanent, Fresher
Pay: ₹20,000.00 - ₹30,000.00 per month
Benefits:
Work Location: In person
