Company Description
About Sutherland:
Artificial Intelligence. Automation. Cloud engineering. Advanced analytics. For business leaders, these are key factors of success. For us, they’re our core expertise.
We work with iconic brands worldwide. We bring them a unique value proposition through market-leading technology and business process excellence.
We’ve created over 200 unique inventions under several patents across AI and other critical technologies. Leveraging our advanced products and platforms, we drive digital transformation, optimize critical business operations, reinvent experiences, and pioneer new solutions, all provided through a seamless “as a service” model.
For each company, we provide new keys for their businesses, the people they work with, and the customers they serve. We tailor proven and rapid formulas, to fit their unique DNA. We bring together human expertise and artificial intelligence to develop digital chemistry. This unlocks new possibilities, transformative outcomes and enduring relationships.
Sutherland
Unlocking digital performance. Delivering measurable results
Job Description
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.
Qualifications
- 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
