GE HealthCare Lead Safety Engineer 

India, Karnataka 

752386583

Activities contributing to the design and development of products, solutions and systems. Includes activities linked to technical improvement of existing products and components Impacts departmental operations and responsible for planning/execution. The role has some autonomy but is focused on execution of activities within an operating discipline covered by standard functional practices and procedures. Some judgment may be required but this is typically with guidance.The Lead Safety Engineer is responsible for GE Healthcare products qualification & certification. The Safety Lab primarily tests medical devices and systems listed below per the requirements of IEC 60601-1, Medical Safety Standards-3rd & 4th Edition, IEC Particular IEC 60601-X-XX and collateral Standards IEC 60601-1-X. Medical Products that are developed at Bangalore site – CT (Computer Tomography), X-Ray, Mammo, MRI (Magnetic Resonance Imaging), Bone Densitometer, C-Arm Machines, Monitoring Machines / Bedside Monitors, Anesthesia / Ventilator Systems, Infant Baby warmers & incubators, Fetal Monitors, Electrocardiography / ECG Machines, X-Ray tubes, Power Systems for CT/MRI machines.Additionally, The Lead Safety Engineer is responsible for the operations of the Environmental, Vibration, 3D Printing & EMI/EMC Lab supporting compliance testing of GE Healthcare products. The Lead Safety Engineer will be responsible for day-to-day operations of these labs, ensuring compliance with IEC/ISO 17025 standard, accreditation requirements & compliance with GE Healthcare QMS.

Roles and Responsibilities

• Developing in-depth knowledge of a technical discipline. Uses prior experience and acquired technical expertise to execute policy/strategy.

• In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

• Uses some level of judgment and has ability to propose different solutions outside of set parameters but with guidance. Uses prior experience and on-the-job training to solve straightforward tasks. Has access to technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

• A job at this level is likely to be an individual contributor with proven interpersonal skills or an early people leader who can hire and develop talent. Provides informal guidance to new team members.

• Lead Safety, Environmental & EMI/EMC Lab for all the operations & accreditations, Manage day to day operations of Laboratory.

• Ensure compliance with ISO/IEC 17025 requirements (NABL/A2LA).

• Collaborate with global lab’s in Waukesha USA, Beijing China & Buc France to leverage best practices.

• Work with global teams to establish standard processes & procedures.

• Capture requirements from Modality teams, regulatory changes to the standards & accordingly propose the roadmap for the lab. Come up with business proposal & drive the investment.

• Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible.

• Maintain training and competency level required to run equipment and perform testing per the appropriate standards and procedures.

• Participate in required trainings (external / global sites) to ensure required technical competency is gained.

• Work with external agencies for the Certification (CTF) / accreditation (NABL) of the Lab’s.

• Perform tests as per the Safety Test Plans and associated standards, Guide / Write and Review Safety Product Test Plans.

• Assists modality engineers in identifying and solving Safety requirements as per the standards.

• Compile test results and complete Safety Test Reports for submittal to Modality Safety Leader.

• Maintain training and competency level required to run equipment and perform testing per the appropriate standards and procedures.

• Oversee EMI/EMC, Environmental & Vibration, 3D Printing laboratory test equipment: Assure all equipment is operational and calibrations are current. Maintain operation of all automated equipment and test control software. Define new equipment needs per changes and additions to the test standards.

• Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible.

• Perform testing as per the test plan or standard test methods for - Safety, EMI/EMC, Environmental & Vibration.

• Work with external agencies for the Certification / accreditation of the Lab’s.

• Ensure Lab Engineers are trained for required skills to ensure smooth operation of the labs.

• Mentor and Assist with training of Modality Safety Engineers and Technicians to assure competency level of individuals performing tests are appropriate per the relevant standards and procedures.

• Capture requirements from customers, regulatory changes to the standards & accordingly propose the roadmap for the lab. Come up with business proposal & drive the investment.

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

• Keep up-to-date on knowledge and understanding of current regulatory requirements for test laboratory within area of responsibility to ensure laboratory accreditations are maintained

• Complete all tests in compliance with procedures and regulations

• 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

• Effectively support implementation & training of current regulatory requirements

Required Qualifications

• This role requires advanced experience in theEngineering/Technology& Electronic Hardware. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience) with a minimum of 6+ years of professional experience in technical capabilities.

• Relevant industrial experience in the regulated medical device industry or similar industry.

• Experience in Design & Development, Testing, Qualification, Certification of the Products with IEC or equivalent standards.

• Good working knowledge of Safety & EMI/EMC regulations: IEC 60601-1, IEC 60601-1-2 Collateral and Particular.

• Good Analytical skills to debug the problems & identify Root cause analysis. Knowledge of RCA, CAPA.

• Awareness of Local and International Regulatory Agencies

• Knowledge of Quality Management Systems including IEC/ISO 17025, Lab Accreditation & Certification.

Desired Characteristics

• Good oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.

• Excellent team-player skills w/global mindset, Excellent interpersonal, organizational, communication and influencing skills.

• Ability to manage multiple activities effectively.

• Ability to communicate effectively with engineers from different disciplines and varying levels of experience.

• Excellent people networking skills.

• Clear thinker, action oriented, high energy, self-starter.

• Effective team player with motivating skills.

Inclusion and Diversity

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.