Principal Engineer - New Product Development/R&D - Spine Division - Medical Devices Firm

Industry - Healthcare / Medical / Hospital

Category - Operations

Job Type - Permanent

Job Description :

- As a NPD Principal Engineer-for the Spine division, the ideal candidate would be a Spine Fusion subject matter expert and be responsible for the Conceptualisation, Design and development of Surgical Instruments

- Co-develop with Strategic Partners and bring to market the Spine Fusion Device

- Collaborate with the Cross Functional Teams to design, test and evaluate various concepts

Client Details

- Our client is a fortune 500 medical device firm headquartered in USA and was the among the first Medical Device organisation to set up a Global Capex Centre in India

Description

- Responsible for conceptualization, design and development of surgical instruments, implants, and cases/trays that are critical to the implant and instrument launches. Co-developing with strategic partners, you will bring to market the spine fusion devices, instruments, and associated cases and trays that are used to organize, transport, store and facilitate sterilization of reusable surgical instruments.

- Specify precise critical product functional requirements, collaborate closely with (and mentor) the cross-functional team to design, test and evaluate various concepts, prototypes and final design for overall effectiveness, cost, reliability and safety

- Conduct mechanical verification and user validation activities, author protocols and reports, build a design history file and be responsible for a timely product launch.

Profile - 

- 12+ years of relevant product development or R&D

- Bachelor's degree in Mechanical Engineering or equivalent, Advanced degree preferred

- Prior experience with designing orthopedic implants and instruments, or equipment and instruments for robot assisted surgery, or instruments for hand assisted laparoscopic surgery.

- Self-starter with demonstrated efficient work methods, analytical & problem-solving skills

- Ability to handle multiple tasks in a fast-paced environment.

- Excellent ability to express ideas and collaborate effectively with multidisciplinary teams

- Excellent written and verbal communication skills

- Innovative thinker that can envision new and better ways of doing things

- Excellent analytical thinker with an ability to plan, organize and implement concurrent tasks

- Knowledge of manufacturing processes, materials, product and process design

- Ability to read and interpret engineering drawings

- Ability to collect user needs and translate into design inputs

- Sense of urgency and commitment to timelines

- Ability to recognize risks in the development process and develop contingency plans

- Prior experience with medical device R&D

- Strong history of cross-functional collaboration with other engineering disciplines (Manufacturing, Electrical, Software, etc.)

- Experience designing for relevant manufacturing processes (e.g. biocompatible material selection - ISO-10993, machining, injection molding, extrusion, metal forming, welding)

- Experience with CAD and FEA modeling software (Solidworks/Pro-E)

- Demonstrated knowledge of medical device design controls (ISO-13485, 21 CFR Part 820) and project management

- Demonstrated expert knowledge of sound design principles and practices including designs compatible with reprocessing, cleaning and sterilization requirements.

- Demonstrated knowledge of risk management techniques

- Demonstrated knowledge of root cause investigation

- Experience applying statistical techniques to inform design decisions (e.g. Design for Six Sigma, Design for Manufacturing ability, Design for Inspection)

- Experience working in a broader enterprise/cross-division business unit model preferred

- Proven track record of employing excellent interpersonal, communication and presentation skills.

Job Offer

- Leadership Role with a new vertical with a Leading Medical Organisation

- Work Life Balance in a leading metro location

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Robin George on +91 124 452 5467.

Contact - Robin George - +91 124 452 5467

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