Finding the best job has never been easier
Share
Roles and 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 GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Required Qualifications:
Bachelor's degree in engineering
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.
Desired Characteristics:
Customer orientation: self-motivated, self-starter with the ability to work independently and learn quickly
Strong interpersonal skills, ability to listen to customer, build relationships, and work under pressure
General project leadership skills
Medical device experience is a plus
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
These jobs might be a good fit