Senior Medical Device Development Specialist

7 days ago

Thrissur, Kerala, India beBeedevelopment Full time ₹ 12,00,000 - ₹ 17,50,000
Job Overview:

We are seeking a highly skilled Medical Device Development Engineer to lead the development of new medical devices, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to drive project goals.

Main Responsibilities:
  • Apply knowledge of medical device regulations and execute gap assessments, manufacturing print reviews, and remediation activities.
  • Coordinate with suppliers to resolve technical queries, ensure timely, and high-quality project delivery.
  • Communicate effectively with cross-functional teams to drive collaboration, technical reviews, and achieve project goals.
  • Prepare 2D/3D drawings/models for assemblies and components (such as plastics/metals/packaging) in compliance with ASME standards, with expertise in GD&T.
  • Conduct, review, and update models for tol-stackup studies and dimensional variation analysis (1D/2D) using Creo-CETol or other tools.
  • Manage CAD data and change orders using windchill/Agile PDM.
  • Participate in ideation activities to assess project scoping and viability through economic analysis, conflict analysis, and supplier quote validation.
  • Work independently with minimal supervision, taking the initiative to determine and develop effective solutions.
  • Apply project management skills to plan, schedule, and monitor project activities efficiently, ensuring FTR & OTD excellence.
  • Conduct root cause analysis to resolve design and process issues.
Essential Qualifications:
  • Bachelor's degree in mechanical engineering with 6-8 years of relevant experience.
  • Proficiency in Creo and Solid Works (drafting and modeling), with hands-on experience in PLM/PDM preferably Windchill.
  • Strong verbal and presentation skills for effective collaboration with global teams.
  • Well-versed with MS Powerpoint, Excel for reports preparation, data analysis, and advance operations.
  • Experience in creating production drawing using GD&T.
  • Tol-stack up (1D/2D/3D) studies for dimensional analysis using tools (excel, CETol).
  • Experience in concept development and prototyping.
  • DFMEA, PFMEA, and design control procedures.
  • Project management skills to develop clear project plans, timelines, and milestones.
  • Engineering Change management and sustenance engineering.
  • Understanding of Supplier quote validation.
  • Good manufacturing knowledge for materials such as plastic, metals, packaging, and sheet metal.
Nice to Have:
  • Medical Device Experience.
  • Knowledge of electronics, cable, connectors, PCBA manufacturing methods.
  • Should costing and quote validation experience in materials like metals, packaging, and plastic.
  • VAVE experience for cost-down project execution and certification (SAVE/INVEST).
  • Exposure to PPAP deliverables.
  • Six Sigma methodology (DFSS/DMAIC).
  • Minitab, Statistical analysis.

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