Job Description: 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 NX or 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.
- Integrate the electronic elements into the product 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
- 3-5 Years of experience in product design.
- Minimum 3 years of experience in the design and development of mechanical or electro-mechanical drug delivery devices (EX. pen injectors, auto-injectors and wearable pumps) or any healthcare, medical devices.
- Expertise in Plastic injection molding process and product development
- Design for Manufacturability (DFM) experience focusing on plastic