Phillips-Medisize, India is seeking a Product Design Engineer to design and develop drug delivery devices, following the Phillips-Medisize Design Development Process (DDP) and applicable standards such as ISO 13485 & ISO 14971 with design controls.
Responsibilities:
Operate primary CAD systems such as SolidWorks or Creo
Identify and analyze design risks using tools such as tolerance analysis, static or agile simulation or theoretical design calculations.
Develop appropriate design risk mitigations and test strategies using dFMEA & pFMEA
Develop appropriate assembly and test fixtures to aid in the manufacture and testing of the design.
Develop appropriate drawings to detail part and assembly specifications in a manner compliant with ASME Y14.5 & ISO 1101 or other design standards
Generate Database Approval Forms and Engineering Change Orders to document design changes and customer approval.
Ensure that design inputs and outputs are properly documented and controlled according to relevant SOP, WI process.
Set up and Perform engineering test for component verification against mechanical specification.
Design/selection of components used in drug delivery devices such as springs, elastomers, plastic parts, sheet metal components,
Selection of material for plastic, metal, and elastomeric parts that are interacting with the drug
Other duties as assigned.
Required Qualifications:
BE/B. Tech in Mechanical Design or Mechanical Engineering or Mechatronics.
Minimum 3 years of experience in the design and development of mechanical or electro-mechanical devices.
Expertise in Plastic injection molding process and product development
Design for Manufacturability (DFM) experience focusing on plastic injection molding and plastic assembly methods (snaps, sonic welding, press fit, sealing, bonding, etc). Design for Assembly (DFA) experience focusing on Low & High Volume assembly line.
Skills And Abilities
Familiar with ISO 13485 and ISO 14971
Minimum 3 years