Senior Design Engineer-Packaging NPI

  • Gurugram
  • Alten

Responsibilities and duties:

  • with technical SMEs, Global packaging Design team and Global vendors and develop Packaging components for Trauma Extremities Projects.
  • technical ability in creating/reviewing Engineering drawings and models and having hands on experience on Creo/SolidWorks etc.
  • and conduct preliminary feasibility design testing for all new packaging design/concepts.
  • technical knowledge in materials, manufacturing processes and DFM applied to test, analyse, and optimize design.
  • closely with the Packaging NPI team peers, R&D Hardware, BML, Quality, Operations, Regulatory, Clinical, Marketing, Labeling and vendor across geographies to ensure project success and improve the customer experience.
  • Audits, Non-Conformances and CAPAs as needed.
  • Good Document practices (GDP) for all documentation created and staying current on all required training.
  • understanding of Design Controls procedures and Industry standards in Medical Device Packaging Design and Testing.
  • team values and demonstrate enthusiasm and commitment to the Packaging Groups organizational vision, high degree of participation in problem solving and decision making both locally and globally.
  • frequently across all project disciplines to ensure project team and senior management are aware of upcoming milestones and risks/issues.
  • communication and knowledge of compliance regulations and standards including IS0 1160-1&2, 21CFR820, ISO13485 and ISO14971 throughout the design and development process.


Experience/Skills required:

  • in Packaging/Mechanical Engineering.
  • years of relevant work experience.
  • understanding of design of medical device Packaging and Labeling.
  • understanding of Design Verification and Validation and Design review process as per the requirement.
  • good knowledge of the Packaging material selection for different levels of packaging.
  • on the PLCM softwares like Windchill/SAP etc.
  • technical ability in understanding of DFM/DFI.
  • have excellent Interpersonal and Communication skills.