Senior Mechanical Design Engineer

UST; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

UST is seeking a highly experienced Mechanical Design Engineer in Pune to lead advanced product development efforts. The role requires 12+ years in mechanical design, strong SolidWorks expertise, and a proven track record in NPIs for medical devices.

You will work with suppliers and cross-functional teams to drive design verification, validation, and risk management activities. Preferred candidates will have familiarity with ISO 13485 and FDA design controls, as well as experience with FMEA

Qualifications

• 12+ years of experience in Mechanical Design and Product Development.
• Strong expertise in SolidWorks and mechanical engineering fundamentals.
• Proven experience in NPI/NPA projects.
• Experience in product design and development.
• Design verification and validation.
• Test planning and execution.
• Root cause analysis and problem-solving.
• Strong knowledge of GD&T and manufacturing processes.
• Experience working with suppliers, contract manufacturers, and cross-functional teams.
• Ability to independently drive projects and resolve technical challenges.
• Experience in Medical Device domain.
• Knowledge of ISO 13485, FDA design controls, and medical product development processes.
• Experience with risk management methodologies (FMEA, DFMEA, PFMEA).
• Exposure to regulatory and compliance requirements for medical products.

Skills

Mechanical design

SolidWorks

NPI

Design verification

Test planning

Root cause analysis

GD&T

Manufacturing processes

Supplier collaboration

Cross-functional teams

Project ownership

Tools

SolidWorks CAD

Job description

• 12+ years of experience in Mechanical Design and Product Development.
• Strong expertise in SolidWorks and mechanical engineering fundamentals.
• Proven experience in NPI/NPA projects.
• Extensive experience in:
• Product design and development
• Design verification and validation
• Test planning and execution
• Problem-solving and root cause analysis
• Strong knowledge of GD&T and manufacturing processes.
• Experience working with suppliers, contract manufacturers, and cross-functional teams.
• Ability to independently drive projects and resolve technical challenges.

Preferred Qualifications

• Experience in the Medical Device domain.
• Knowledge of ISO 13485, FDA design controls, and medical product development processes.
• Experience with risk management methodologies (FMEA, DFMEA, PFMEA).
• Exposure to regulatory and compliance requirements for medical products.