Lead Safety Engineer
Lead Safety Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Description Summary
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 606011 Medical Safety Standards3rd & 4th Edition IEC Particular IEC 60601 and collateral Standards IEC 606011X. Medical Products that are developed at Bangalore site CT (Computer Tomography) XRay Mammo MRI (Magnetic Resonance Imaging) Bone Densitometer CArm Machines Monitoring Machines / Bedside Monitors Anesthesia / Ventilator Systems Infant Baby warmers & incubators Fetal Monitors Electrocardiography / ECG Machines XRay 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 daytoday operations of these labs ensuring compliance with IEC/ISO 17025 standard accreditation requirements & compliance with GE Healthcare QMS.
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 worldchanging realities and join an organization where every voice makes a difference and every difference builds a healthier world.
Job Description
Roles and Responsibilities
Developing indepth knowledge of a technical discipline. Uses prior experience and acquired technical expertise to execute policy/strategy.
Indepth understanding of key business drivers; uses this understanding to accomplish own work. Indepth 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 onthejob 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 labs 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 Labs.
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 Labs.
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 uptodate 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
Bachelors Degree in STEM Majors (Science Technology Engineering and Math) 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 606011 IECCollateral 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 teamplayer 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 selfstarter.
Effective team player with motivating 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 worldchanging 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.
#LIAM11
Additional Information
Relocation Assistance Provided: Yes
Employment Type
Full-Time
