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Medical Device Design Lead

Medical Device Design Lead

Tata Consultancy ServicesBengaluru, Republic Of India, IN
3 days ago
Job description

We are hiring for Technical Lead – Medical Device Design and Development

Experience Range -8 to 10 years.

Location - Bangalore, Pune, Kolkata, Chennai, Bhubaneswar, India

Job description -

  • 8+ years of experience in orthopedics medical device product design and development. Preferably in new product development.
  • Understanding of EU MDR (European Medical Device Regulation), FDA, ISO 13485, ISO 14971 requirements for medical devices.
  • Strong experience in CAD NX (drawing, model, assembly etc.) and tolerance stack up analysis.
  • Excellent understanding of GD&T principles.
  • Knowledge to read and interpret information from Product design documents (CAD models and drawings etc.) and engineering analysis reports such as FEA
  • Experience in medical device risk assessment techniques, design failure mode effect analysis (DFMEA), design control plans, product complain analysis.
  • Understanding of various aspects of a Design History File (DHF) for medical device development.
  • Experience in PLM change management (Windchill preferred)
  • Should have led multiple large NPD / Reengineering / Value Engineering / Design Refresh programs

Roles & Responsibilities

  • Responsible design and development of medical devices instruments and implants
  • Create CAD models and drawings using CAD tools (preferably NX)
  • Apply GD&T as appropriate and perform tolerance stack-up analysis (2D and 3D)
  • Create and update requirement matrix / design control plans, DFMEAs, risk management reports and other associate documents as needed per the Design history file
  • Interact with cross-functional team on a day-to-day basis to expedite the technical activities
  • Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem-solving skills.
  • Excellent influencing skills, decision making skills, and problem-solving skills.
  • Generic Managerial Skills, If any

  • Required to have good communication skills both written & verbal and be computer literate (Word, Excel, outlook Email - a must).
  • Strong interpersonal, organizational, written and oral communication skills
  • Dependable, somewhat assertive, reasonably organized, resourceful and communicative with an ability to adapt and learn quickly as well as follow verbal and written instruction, detail oriented.
  • Collaborate with cross-functional teams across multiple customer sites and suppliers Strong organizational & interpersonal skills.
  • Ability to perform multiple projects simultaneously and work under deadlines, pressure and fast turnarounds.
  • Project Management Certification preferred.
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    Design Lead • Bengaluru, Republic Of India, IN

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