Technical Lead – Medical Device Design and Development

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.