Senior Design Engineer-Packaging NPI

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.