Software Engineer Development or Testing

Roles & Responsibilities

• Represent the design team and design control process from requirements development and design planning to design transfer & experience with product lifecycle
• Lead development of requirements flow down, Architecture/System design and analysis, risk analysis, Cybersecurity analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction.
• Collaborate closely with cross-functional teams to ensure that regulatory/country specific requirements and outputs are defined.
• Work closely with cross functional teams across sites to manage technical program risks, integration risks and design tradeoffs.
• Work to ensure QMS compliance, DHF readiness & regulatory to ensure Ultrasound product is regulatory compliance and commercialization.
• Contribute towards product strategy, drive architecture decisions, and design solutions to resolve challenging customer problems.
• Experience with IEC60601 standards and Product safety regulatory standards
• Experience with ISO13485, FDA, MDR, etc
• Experience in managing defect resolution activities for design changes, including analysis and defect disposition
• Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.

  Roles & Responsibilities

• Represent the design team and design control process from requirements development and design planning to design transfer& experience with product lifecycle
• Lead development of requirements flow down, Architecture/System design and analysis, risk analysis, Cybersecurity analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction.
• Collaborate closely with cross-functional teams to ensure that regulatory/country specific requirements and outputs are defined.
• Work closely with cross functional teams across sites to manage technical program risks, integration risks and design tradeoffs.
• Work to ensure QMS compliance, DHF readiness & regulatory to ensure Ultrasound product is regulatory compliance and commercialization.
• Contribute towards product strategy, drive architecture decisions, and design solutions to resolve challenging customer problems.
• Experience with IEC60601 standards and Product safety regulatory standards
• Experience with ISO13485, FDA, MDR, etc
• Experience in managing defect resolution activities for design changes, including analysis and defect disposition
• Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
• Bachelor's degree in Engineering preferably with mechanical background
• 8+ years relevant work experience.
• Preferably with System or HW background
• Experience working with supply chain, suppliers, and product management.
• Hands-on approach with regards to installations, upgrades and repairs
• Strong problem solving, analytical, trouble-shooting skills