Lead Systems Engineer

Smith+Nephew

Pune, India
Not specified; not specified; major medical covera...
Hybrid
Systems engineering for medical devices
Electrical design and integration expertise
Iec 62304 iec 60601 iso 13485 compliance
Smith+Nephew is seeking a Lead Systems Engineer for their Kharadi, Pune location to oversee systems engineering activities for new product development in advanced medical devices, particularly focusing on electrosurgical devices. The ideal candidate should have extensive experience in electrical design, systems architecture, and medical device standards, along with strong leadership and collaboration skills

Job Summary

  • Join Smith+Nephew's dynamic ENT R&D team to drive systems engineering activities for advanced medical device new product development.
  • The role requires extensive knowledge of electrical systems, embedded firmware, and adherence to strict medical device standards like IEC 62304 and ISO 14971.
  • Employees enjoy benefits including major medical coverage, flexible personal time off, free cab transport, and a hybrid work model.

Matching Summary

Match Score: 85

Smith+Nephew is seeking a Lead Systems Engineer for their Kharadi, Pune location to oversee systems engineering activities for new product development in advanced medical devices, particularly focusing on electrosurgical devices. The ideal candidate should have extensive experience in electrical design, systems architecture, and medical device standards, along with strong leadership and collaboration skills.

Salary

Not specified; Not specified; Major medical coverage; Educational Assistance; Free Cab Transport

Skills & Requirements

Must-have

  • Systems engineering for medical devices
  • Electrical design and integration expertise
  • IEC 62304 IEC 60601 ISO 13485 compliance
  • Embedded firmware RTOS bare-metal development
  • Risk management and validation strategies
  • Cross-functional team leadership and mentorship

Nice-to-have

  • Software as Medical Device SaMD experience
  • Innovation in electrosurgical technologies
  • Strong problem-solving analytical skills
  • Experience with Cognition Cockpit tools
  • Model-based systems engineering proficiency

Key Requirements

  • BS MS or PhD in Electrical Engineering or related field
  • 6+ years experience (BS) or 3+ years (MS) in medical device development
  • Proven track record leading large-scale R&D projects
  • Advanced understanding of FDA/MDR guidance and safety testing
  • Certifications such as Systems Engineering Professional (SEP) preferred

Work Rights

Not specified

Tailored Resume

Cover Letter