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Lead System Designer

Bengaluru, KA
Job Code:
  • Manufacturing & Production
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Job Details

1. Working on a team responsible for new product development2. Working closely with cross-functional groups in delivering effective new product development process results 3. Leading technical risk retirement across subsystems4. Handling cross-functional program activities for software programs 5. Ensuring compliance with Design History File (DHF) and other QMS requirements6. Managing quality objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives 7. Ensuring that quality targets are met and technical risks are retired8. Leading the design team and design control process from requirements development and design planning to design transfer 9. Leading the design team in the development of verification and validation planning and execution10. Developing requirements flow down, architecture/system design and analysis, risk analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction 11. Driving the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and qualityQuality-Specific Goals 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required4. Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones 5. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiativesQualifications/Requirements1. Bachelor's Degree in Computer Science, Mechanical, Electrical or Biomedical Engineering or equivalent2. 5 years experience in design and development of medical equipment technologies 2. Demonstrated ability to work in a cross-functional project team and to drive project design plans to completion3. Strong understanding of the GEHC Quality Management System 4. Familiarity with ISO, FDA and other regulatory standards5. Exposure to software development practices and SDLC 6. Exposure to Agile development practicesDesired Characteristics1. Strong verbal and written communication skills2. Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues 3. Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program4. Strong interpersonal skills 5. Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program6. Exposure to medical visualization applications and quantification 7. Familiarity with clinical workflows
Degree: MCA/ PGDCA | ME/ M.Tech./ MS (Engg/ Sciences)

Additional Degree: BE/ B.Tech (Engineering) | BCA (Computer Application)

Experience: 5-10


Application Programming | Graphic Designing/Animation/Web Designing | Software Engineer | Systems Programming
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