TS_101: : Mechanical Engineer R&D-Solidworks

JD:-
Key Result Areas

• Design and develop the Mechanical designs for new generation of medical devices.
• Develop design solutions, at component and final assembly level, to complex technical problems.
• Define protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s).
• Performs work under general supervision on multiple NPI projects while technical objectives of assignment.

Superior's Signature / Date
PURPOSE OF THE POSITION:
Design and develop mechanical design, prototype, manufacturing drawings and verification for innovative medical devices and solutions.

Major Responsibilities

• Support the design and development of new medical products to meet customer requirements within scope (e.g., performance and quality), schedule (e.g., on time delivery), and budget (e.g., price) constraints.
• Support development of design solutions, at component and final assembly level, to complex technical problems where analysis of data requires an in-depth evaluation of many factors. Solutions require use of ingenuity and creativity.
• Translate customer's product requirements into achievable product specifications and design features.
• Support FMEA (Failure Mode Effects Analysis) and risk analysis reviews on NPI (New Product Introduction) products.
• Support a series of cross-functional design reviews throughout the NPI process.
• Document product development progress conforming to operating procedures of the Product Lifecycle.
• Coordinate proof-of-concept and design verification testing and write final test reports for

communication with internal and external customers with minimal support.

• Ensure new designs meet relevant Design History File (DHF) requirements.
• Resolve quality problems associated with design and act as a technical resource to other cross- functional engineers as needed.
• Implement design improvements on legacy products for cost savings.
• Work effectively with cross-functional core team members.
• Maintain current knowledge of best practices, new technologies, and equipment .
• Work closely with suppliers, sourcing, manufacturing, and service teams to realize project goals.
• In addition to the above you may be given additional responsibilities as per business requirement and your JD can be altered at the discretion of your superiors.

REQUIREMENT PROFILE:
(Qualification, No of yrs exp)

• Bachelor's / Master's degree in Mechanical engineering.
• 4+ years of industry experience in concept to delivery of medical devices design and development.
• Knowledge of regulations relating to mechanical design in medical device industry.

COMPETENCIES:
(knowledge, skills and attitudes required to perform job):

• Fair knowledge of materials, manufacturing processes (e.g., plastic injection molding, machining, anodizing, soldering, automated assembly), sterilization, cable interconnect assemblies, bulk cable design principles, and advanced statistical techniques.
• Fair knowledge of PCBA design and processing
• Six Sigma Green or Black belt is a plus.
• Technical contribution through creative product design solutions that have been successfully launched into the market.
• Hands-on experience with mechanical CAD tools (Preferred Solid works, ePDM) for assembly design, parts design and BOM creation, GD&T and Prototype creation.
• Knowledge in Finite Element Analysis (FEA) theory and experience in performing mechanical and mold flow simulations.
• Working knowledge of additive manufacturing processes for rapid prototyping.
• Exposure to JMP and/or Minitab Statistical Analysis applications a plus

Desired

• Hands on experience in design and development of motion control, co-ordinate movement based medical devices.