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Job Description SummaryAs Lead System Designer, your primary responsibility is to serve on the program team to deliver successful and timely NPI and ATD programs. In this role, you will work on AI product development, managing the interface between Development and Quality Compliance together with a cross-functional team. This role is initially within the newly acquired Intelligent Ultrasound clinical AI team but will work together with teams from other ultrasound segments. Candidates for this role are located in United Kingdom.
Job Description
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
The GE HealthCare Ultrasound business consists of ultrasound consoles, handheld ultrasound devices, and ultrasound IT solutions across 5 different market segments. There is a strong emphasis on development of AI solutions for our ultrasound products so we can create additional value for customers and patients. We aim to grow our offerings via organic as well as inorganic developments.
Essential Responsibilities:
- Ensure that product programs achieve all design objectives required to meet customer and business needs, including: feature and functionality, quality, reliability, serviceability, manufacture-ability, regulatory, compliance, and cost.
- Drive the end-to-end product development process from requirements capture to V&V and commercial release.
- Drive compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones;
- Lead the design team and design control process from requirements development, design planning to design transfer
- Lead the design team in the development of verification and validation planning and execution for NPIs and released products
- Develop 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
- Ensure that the quality targets are satisfied and technical risks are addressed as they arise on the program or released product
Quality Specific Goals:
- 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
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives
- Responsible for the validation of all GxP relevant applications and maintaining the validated state of those applications
- Aware of and comply with the change management work instruction
- Develop an open quality culture within the organization that fosters issue discussion and decision-making based on quality and compliance objectives
Basic Qualifications:
- Bachelor’s or Master Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math);
- Considerable experience in software or medical product development, program management, and/or related field, leading cross functional programs, life-cycle management, and/or large global projects; experience with AI development would be an advantage;
- Demonstrated experience with New Product Introduction (NPI) regulatory compliance process, design history file and related documentation;
- Relevant experience in project leadership within engineering environment;
- Demonstrated experience driving requirements development and management and flow-down to subsystems while ensuring traceability between design and test procedures;
- Excellent influencing, interpersonal and communications skills (both written and verbal) with all levels of an organization; able to build good working relationships
- Self-starter - requires minimal direction to accomplish goals, proactive and enthusiastic
- Strong team player – collaborates well with others to solve problems and actively incorporates input from various sources
- Strong presentation skills - effectively able to present status, risks, and plans to senior leaders
- Willing to travel
Desired Characteristics:
- Master’s Degree in Computer Engineering/Computer Science or equivalent degree with 8 to 10 years’ experience in industry
- Strong knowledge of GEHC Phase Review Discipline (PRD) and regulatory process for medical device development
- Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
- Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program
- Demonstrated ability to balance multiple program priorities while meeting critical commitments
- Demonstrated ability to work in a global matrixed organization and deliver results in an ambiguous environment
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Total Rewards
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
Inclusion & Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law.
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Additional Information
Relocation Assistance Provided: No
