Senior Manager Clinical Validation
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Job Location:
Monthly Salary:
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description Summary
The Clinical Validation Manager will lead a team of Imaging Technologists and Radiologists to validate SEI products from a clinical perspective ensuring compliance with established processes and regulatory standards. This role requires strong radiology domain expertise across multiple modalities a solid foundation in functional skills and knowledge of relevant technologies. The manager will coordinate cross-functional teams to define and realize a modern user experience within SEI focusing on optimal workflows user-centered design principles and customer needs.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
Job Description
Key Responsibilities:
- Lead clinical validation activities for SEI products ensuring adherence to regulatory and QMS requirements
- Develop and maintain clinical validation protocols test cases and documentation aligned with product requirements.
- Ensure traceability between clinical requirements validation results and regulatory compliance.
- Collaborate with engineering and product teams to translate clinical and user requirements into actionable deliverables within Agile/Scrum frameworks.
- Engage early in the development cycle to provide clinical feedback and risk assessments.
- Validate SEI products from an end-user perspective within defined timelines.
- Work directly with end users to capture workflow challenges and incorporate insights into product design.
- Assess modern analytics and AI/ML technologies for clinical applicability.
- Coordinate usability testing and clinical risk analysis with UX and product management teams.
- Provide clinical education and guidance to global engineering teams.
- Drive continuous improvement in validation processes and QMS compliance.
Educational Qualifications:
- Bachelors degree in Radiology & Imaging or related field.
- Minimum 15 years experience in the medical imaging industry.
Required Skills :
- Strong knowledge of multi-modality radiology workflows and systems.
- Experience in clinical validation risk management and QMS compliance.
- Excellent oral and written communication skills.
- Strong analytical and process-oriented mindset.
- Ability to work effectively in a collaborative matrixed environment.
Desired Characteristics
- Masters degree in Radiology & Imaging.
- Familiarity with clinical risk management
- Ability to lead diverse cross-functional teams globally.
- Experience with SAFe Agile methodology.
- Understanding of user experience design and usability testing.
- Knowledge of AI/ML applications in imaging workflows.
- Strong leadership negotiation and stakeholder management skills.
Inclusion and 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 expression age disability protected veteran status or other characteristics protected by law.
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.
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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
#EveryRoleIsVital
#LI-SM1
Additional Information
Relocation Assistance Provided: Yes
Required Experience:
Senior Manager
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
GE HealthCare provides digital infrastructure, data analytics & decision support tools helps in diagnosis, treatment and monitoring of patients
