Duties include (but are not limited to):
Perform EMI/EMC tests of Imaging (CT, MRI, PET, X-Ray, Mammo, C-Arm, Bone Densitometer) & Clinical care (Anesthesia & Respiratory Care, Ventilators, Incubators, Baby Warmers, Fetal Monitoring Systems, Bedside Monitors, Central Stations, ECG Machines) products.
Assists modalities in identifying and solving Safety & EMI/EMC related issues in NPI Designs.
Review Safety Product Test Plans & EMI/EMC Test Plans.
Compile test results and complete Test Reports for submittal to Modality.
Maintain training and competency level required to run equipment and perform testing per the appropriate standards and procedures.
Oversee Safety, 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.
Work with external agencies for the Certification (CTF) / accreditation (NABL) of the Lab’s.
Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible.
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.
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
Qualifications:
Bachelors in Electrical / Electronics
10 ~ 12 years of 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.
Strong 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 a New Product Introduction process
Knowledge of Quality Management Systems including IEC/ISO 17025, Lab Accreditation & Certification.
Excellent team-player skills w/global mindset
Excellent interpersonal, organizational, communication and influencing skills
Working knowledge of GEHC products
Ability to manage multiple activities effectively.
Ability to communicate effectively with engineers from different disciplines and varying levels of experience.
Strong people networking skills.
Clear thinker, action oriented, high energy, self-starter.
Effective team player with motivating skills.
Strong working knowledge of English language (oral and written)
Preferred Qualifications:
Previous experience in an ISO/IEC 17025 accredited lab
Knowledge of process improvement tools (six sigma, lean, ISO, TQM)
Strong organizational skills with high attention to detail
Adaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations.
Responsibilities
Duties include (but are not limited to):
Perform EMI/EMC tests of Imaging (CT, MRI, PET, X-Ray, Mammo, C-Arm, Bone Densitometer) & Clinical care (Anesthesia & Respiratory Care, Ventilators, Incubators, Baby Warmers, Fetal Monitoring Systems, Bedside Monitors, Central Stations, ECG Machines) products.
Assists modalities in identifying and solving Safety & EMI/EMC related issues in NPI Designs.
Review Safety Product Test Plans & EMI/EMC Test Plans.
Compile test results and complete Test Reports for submittal to Modality.
Maintain training and competency level required to run equipment and perform testing per the appropriate standards and procedures.
Oversee Safety, 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.
Work with external agencies for the Certification (CTF) / accreditation (NABL) of the Lab’s.
Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible.
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.
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
Qualifications:
Bachelors in Electrical / Electronics
10 ~ 12 years of 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.
Strong 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 a New Product Introduction process
Knowledge of Quality Management Systems including IEC/ISO 17025, Lab Accreditation & Certification.
Excellent team-player skills w/global mindset
Excellent interpersonal, organizational, communication and influencing skills
Working knowledge of GEHC products
Ability to manage multiple activities effectively.
Ability to communicate effectively with engineers from different disciplines and varying levels of experience.
Strong people networking skills.
Clear thinker, action oriented, high energy, self-starter.
Effective team player with motivating skills.
Strong working knowledge of English language (oral and written)
Preferred Qualifications:
Previous experience in an ISO/IEC 17025 accredited lab
Knowledge of process improvement tools (six sigma, lean, ISO, TQM)
Strong organizational skills with high attention to detail
Adaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations.
Salary : Rs. 9,00,000.0 - Rs. 25,00,000.0
Industry :IT-Software / Software Services
Functional Area : IT Software - Application Programming , Maintenance
Medical domain expertise, knowledge of HL7,FHIR, hands on experience in TDD. Experience in BDD Automation testing. Knowledge of ALM tool, Junit, NFR testing and reliability testing
Responsibilities
Medical domain expertise, knowledge of HL7,FHIR, hands on experience in TDD. Experience in BDD Automation testing. Knowledge of ALM tool, Junit, NFR testing and reliability testing
Salary : As per industry standard.
Industry :IT-Software / Software Services
Functional Area : IT Software - Application Programming , Maintenance
HL7 Services Team [ Full Stack Java developer - Spring Boot, HL7, FHIR, Kubernetes, Kafka, Grafana, Prometheus, Helm Chart, BDD Automation Test, REST, Microservices and Java. Persons with Azure knowledge will be given preference] - Full Stack Developer Java EXP who has HL7, FHIR knowledge + medical domain.
Responsibilities
HL7 Services Team [ Full Stack Java developer - Spring Boot, HL7, FHIR, Kubernetes, Kafka, Grafana, Prometheus, Helm Chart, BDD Automation Test, REST, Microservices and Java. Persons with Azure knowledge will be given preference] - Full Stack Developer Java EXP who has HL7, FHIR knowledge + medical domain.
Salary : As per industry standard.
Industry :IT-Software / Software Services
Functional Area : IT Software - Application Programming , Maintenance
In this role, He/She will be responsible for creating the parts, and managing the parts in the system. This role is responsible for having a high level of interaction across all departments to ensure the completion of the bill of materials in a timely, efficient, and detailed manner.
Understanding PCS software applications and their regulatory requirements, as well as the engineering design change/control process, verification and validation report reviews, engineering change request reviews, supplier change request reviews, and conducting periodic review of country specific regulatory change notifications and global product standards in compliance with the quality management system are all necessary for this position.
Collaborate closely and communicate with cross functional teams (Engineering, Quality & Regulatory Manufacturing, Suppliers, Sourcing and Materials team) to ensure that engineering changes are implemented in products successfully.
Learn practical application of engineering principles, understand design changes and achieve expertise in product life cycle change management. For this position, it would be ideal to have prior experience in product life cycle management of medical software applications.
Job Description
Roles and Responsibilities
· Responsible for creating Parts and managing the bill of Materials in the system.
· Design, manage, maintain, and optimize EBOM (Engineering Bill of Materials) and configuration BOM to ensure completeness and relevance.
· Evaluate engineering changes and synchronize corresponding BOM (Bill of Materials) changes.
· Become fully competent in using the Bill of Materials maintenance and reports in Product Lifecycle Management (PLM) system.
· Become proficient in setting up new options and/or create rules to support various build configurations.
· Coordinate with stakeholders to ensure content of BOM is always up to date.
· Experienced with Excel, Word, PowerPoint, Outlook Email & Calendar system.
· Prepare executive summaries and escalate issues.
Responsibilities
Bachelor's degree in Engineering (Mechanical, Electrical, Software or any suitable)
Work experience 3 to 5 years.
Had involved in developing and creating the Bill of Materials from the Scratch.
Exposure to the Software applications is preferable.
Experience in working in various different time Zones and Global stake holder
3+ years relevant experience with PLM tools and processes and Bill of Materials, proven experience managing complex stakeholder requirements and relationships.
Technical knowledge of product structure and processes, understanding of PLM tools.
Essential knowledge about the Software and Hardware BOM components.
Skillsets: Strong stakeholder relationship management skills, excellent communication skills, Attention to the details, Problem solving skills. Strong work ethic and a commitment to engineering excellence and data-driven decision making. Works well on projects on their own as well as with a team, able to clearly communicate ideas.
Salary : Rs. 6,00,000.0 - Rs. 20,00,000.0
Industry :IT-Software / Software Services
Functional Area : IT Software - Application Programming , Maintenance
As a node.js developer, you are required to work in scrum team on assigned user stories and tasks.
• Understand business requirements, get clarifications from business users, work on code changes and unit testing, provide support for WA testing in terms of bug fixes, release management and support.
• You need to be proficient in NodeJS and willing to learn any additional technology required.
Responsibilities
As a node.js developer, you are required to work in scrum team on assigned user stories and tasks.
• Understand business requirements, get clarifications from business users, work on code changes and unit testing, provide support for WA testing in terms of bug fixes, release management and support.
• You need to be proficient in NodeJS and willing to learn any additional technology required.
Salary : Rs. 10.0 - Rs. 13.0
Industry :IT-Software / Software Services
Functional Area : IT Software - Application Programming , Maintenance
