Phillips-Medisize, India is seeking a Product Design Engineer to design and develop drug delivery medical 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 stack-up analysis, FEA and design calculations.
Develop appropriate design risk mitigations and test strategies using dFMEA & pFMEA
Design, development, prototype and testing of concepts.
Develop 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.
Generate Engineering Change records following change management process.
Ensure that design inputs and outputs are properly documented and controlled according to relevant SOP, WI process.
Development of test methods and plan for verification of mechanical design specifications.
Design/selection of materials for components used in drug delivery medical devices such as springs, elastomers, plastic parts, sheet metal components.
Selection of material for plastic, metal, elastomeric parts that interacts with the drug.
Required Qualifications:
BE/B. Tech in Mechanical Design or Mechanical Engineering or Mechatronics
2-4 years of experience in the design and development of medical devices preferably drug delivery medical devices such as pen injectors, auto-injectors, wearable pumps etc.
Expertise in Plastic injection molding process and current product development.
Design for Manufacturability (DFM) experience focusing on plastic injection molding and plastic assembly methods (snaps, ultra-sonic welding, press fit, sealing, bonding, etc)
Familiarity with Design controls in compliance with 21 CFR 820.30.