Safety and Regulatory Engineer

GE Healthcare Private Limited; Karnataka; Hybrid; INR 3,500,000 - 4,500,000; Full time

Benefits offered by this job

Relocation assistance provided

Job summary

GE HealthCare seeks a Safety & Regulatory Engineer to lead the development and implementation of product safety engineering methodologies for medical equipment and devices. You will identify and mitigate safety risks, perform rigorous risk assessments, and apply human factors to reduce errors in field operations.

You will ensure compliance with applicable country standards, coordinate with design teams and external parties for testing and certification, and support regulatory strategy across

Qualifications

• Advanced experience in Engineering/Technology & Technical Regulations/Standards.
• Expert level skills in collaborating with stakeholders and influencing decisions.
• Ability to take a strategic view and ensure project quality, performance and schedule.
• Experience across imaging modalities and product safety engineering.

Responsibilities

• Develop and implement product safety engineering methodologies for equipment and devices.
• Identify and mitigate safety risks; perform rigorous safety risk assessments and hazard evaluations.
• Communicate applicable standards to design teams and ensure compliance.
• Coordinate with independent third parties for product compliance testing and certification.
• Interact with external firms or government agencies to obtain regional or national product certifications.

Skills

Regulatory compliance

Safety engineering

Stakeholder collaboration

Regulatory standards

Imaging modalities

Education

Bachelor's degree in Engineering or related field

Job description

Safety & Regulatory Engineer - CT Job Description Summary

Systems engineering is a cross-functional engineering discipline centered on an approach, mindset, and process. All activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the users needs. The discipline that executes a robust process of design, creation, and optimization of systems, consisting of identification and quantification of system requirements, creation of alternate system design concepts, performance of design trade studies, selection and implementation of the best designs and verification that the design is properly integrated and executed. Process that proceeds from concept to production to operation. Responsible for departmental operations planning/execution or is focused on execution of professional activities within a technical discipline. Functions with some autonomy but guided by established policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.). GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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.

Roles and Responsibilities

• Responsible for the theory, design, development and practical implementation of product safety engineering methodologies and techniques for equipment and devices.
• Execute a process to identify and mitigate safety risks inherent to the product design to an acceptable level; conduct rigorous safety risk assessments, hazard evaluations, utilize human factors principles to drive design improvements in order to eliminate human error in the operation and maintenance of the product in the field
• Reviews and understands the applicable standards required by Law in country that apply to the relevant products. Communicates standards to the design community and maintains it.
• May also participate with independent third parties to perform product compliance and certification work (testing, design review etc.) and communicates results/actions to the relevant engineering and supply chain team.
• Interacts with outside engineering firms or governmental agencies to provide or record product compliance to required regional or national standards to gain the needed product certification or qualification.
• Utilizes in-depth knowledge of a technical discipline and analytical thinking and technical experience to execute policy/strategy.
• Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
• Uses some judgment and has some ability to propose different solutions outside of set parameters to address more complicated manufacturing processes with technical variety and/or interdependent production cycles.
• Uses technical experience and analytical thinking.
• Uses multiple internal and limited external sources outside of own teams to arrive at decisions.
• Acts as a resource for colleagues with less experience.
• May lead small projects with low risks and resource requirements.
• Explains information; developing skills to bring team members to consensus around topics within field.

Required Qualifications

This role requires advanced experience in the Engineering/Technology & Technical Regulations and Standards. Knowledge level is comparable to a Bachelor's degree from an accredited university or college Expert level skills in collaborating with different stakeholders, influencing decisions and an ability to take strategic view Demonstrated execution at meeting project goals while satisfying quality, performance, and schedule. Strong analytical and problem-solving skills, effectively evaluates information/data to make decisions, anticipates obstacles and develops plans to resolve. Experience in working across Imaging modalities

Desired Characteristics

• Excellent oral and written communication skills.
• Excellent interpersonal and leadership skills.
• Demonstrated ability to analyze and resolve problems.
• Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion 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 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.

Additional Information

Relocation Assistance Provided: Yes
Experience Level Senior Level
#LI-Hybrid #LI-MP2