Mechanical CAD

Knowledge of medical device regulations (MDR,FDA,CE,IEC)

Hands on expertise on design or engineering documentation gap assessments, manufacturing print reviews and remediation activities.

Participate in ideation workshops to assess project scoping and viability through economic analysis and supplier quote validation for programatic savings projects.

Experienced in product sustenance engineering activities with expertise across design, manufacturing methods (Stamping, Plastics, PDC parts), production processes and regulatory compliance.

Skilled in coordinating with suppliers to resolve technical queries, ensuring timely and high-quality project delivery.

Develop and refine detailed 2D drawings and 3D CAD models to support project requirements.

Hands-on experience in reverse engineering components to recreate CAD models and extract design intent using 1D principals and advanced inspection techniques (e.g., 3D scanning, measurement tools).

DFMEA / PFMEA and design reviews to assess and mitigate design & Mfg risks.

Review and validate engineering drawings for DFMA, Manufacturability, Accuracy and Completeness as per the latest Engineering standards.

Review and validate PPAP reports received from supplier and assess if the technical specifications are met.

Well versed with Engineering Change management procedures using PDM / PLM Softwares (Agile, Windchill, etc.,)

Assist in developing Master Validation Plans, conducting MSA studies, preparing process flow, conducting and reviewing IQ,OQ and PQ studies and documentation.

Hands on expertise for Minitab to perform statistical analysis and studies.

Well versed with MS tools like excel, presentation for reporting and date analysis purpose.

Minimum of 6-8 years of relevant experience.

Bachelor of Engineering in Mechanical or Production engineering.