Redefine Your Future with TransMedics
OCS Production Test Technician II
Redefine Your Future with TransMedics, Andover, Massachusetts, United States, 01810
Organ Care System Production Test Technician II
An Organ Care System (OCS) Production Test Technician II is a critical role in ensuring the reliability and safety of the OCS electrical system, including manufacturing and final test. They play a vital part in preventing electrical failures and ensuring compliance with regulatory standards. An OCS Production Test Technician II is responsible for testing, troubleshooting, and inspecting PCB Boards, Sub-Assemblies and Organ Care systems, and components to ensure they meet quality standards, safety regulations, and performance system specifications. Responsibilities
This position is responsible for, but not limited to, the following: Conduct electrical tests and Burn-IN on various components, PCB boards, sub-assemblies and Organ Care Systems to identify defects, malfunctions, or non-compliance with specifications with no non-conformances write ups. Assemble and/or Disassemble Devices per engineering documents and drawings or non-comformance's instructions. Use testing equipment (but not limited to) such as multimeters, oscilloscopes, function generators and hipot tester to measure voltage, current, resistance, and other electrical parameters. Maintain efforts to ensure all production test related activities are executed in a timely manner to satisfy Company's Production schedule and quality standards Provide training in testing and inspection methods as required. Assist Test Technicians I in all areas of testing department such as testing, troubleshooting, documentation, calibrations, efficiency, LEAN etc. Assist Engineering staff in completion of quality and regulatory activities related to product development, maintenance and/or repair. Support Engineering team and Production team efforts to identify opportunities to streamline production through Assist process, test and product design changes. Test Engineering in the troubleshooting and development of new test equipment and protocols. Support Lean, Health and Safety Initiatives. Perform other TransMedics tasks and duties as required. Troubleshooting
Perform visual inspections of electrical components and systems to identify physical damage, loose connections, or signs of wear and tear. Assist Test Engineers/Engineer Techs in the diagnose and troubleshooting of all electrical issues to determine the root cause of problems and recommend corrective actions. Analyze test data and results to identify patterns or anomalies that indicate potential issues. Repair and Maintenance
Perform basic repairs and maintenance tasks on electrical systems and equipment, such as replacing faulty components or connectors. Ensure that all monthly in-house calibration and preventative maintenance tasks on electrical systems and equipment are up to date. Ensure that all equipment and tools used for testing and maintenance are properly calibrated and in good working condition. Documentation
Maintain detailed records of test procedures, results, route sheets, and maintenance activities. Prepare test reports and documentation to report findings and provide recommendations for improvements or repairs. Initiate Non-Conforming Materials when Applicable. Safety Compliance
Adhere to safety regulations and guidelines while working with electrical systems and equipment. Ensure that all tested equipment and systems meet safety standards and requirements. Maintain individual work area and equipments in a neat orderly manner according to standards including proper disposal of packaging waste, proper storage and use of equipment and parts and management of documentation needed to perform duties. Quality Assurance
Verify that electrical systems and components meet quality standards and specifications. Collaborate with engineering and quality control teams to address any non-conformities and implement corrective actions. Work with Quality Assurance to maintain an approved internal Quality System that meets the requirements of FDA 21CFR820 and ISO 13485 standards. Comply with all work safety rules and regulations. Communication
Communicate test results, findings, and recommendations to relevant stakeholders, including engineers, supervisors, and managers. Provide technical support and guidance to other team members or technicians as needed. Perform other TransMedics tasks and duties as assigned/required. Minimum Qualifications
High school diploma or equivalent; an associate degree or certification in electrical technology or a related field with 4+ years experience. High level of proficiency in fabrication, assembly and testing required Familiarity with test equipment/procedures including but not limited to oscilloscopes, power supplies, function generators, Hipot testing and digital multimeters. Experience with testing of Printed Circuit Boards and electronic testing. Ability to follow written instructions or procedures such as mechanical assembly drawings, electrical schematics, assembly procedures, test procedures and validation procedures. Must have effective analytical and decision-making skills with a keen focus on quality and accuracy to ensure that all work assignments meet corporate quality and regulatory requirements. Must possess a strong work ethic, effective oral and written communication skills and excellent interpersonal skills. Self-starter with a strong initiative, outstanding judgment and ability to work in a fast-paced environment with demonstrated ability to adjust to changing priorities. Preferred Qualifications
Experience with IPC Standards including J-STD-001 Soldering Electrical and Electronic Components, IPC-A-610/620 PCB and Wire Harness Inspection and IPC-7711/7721 Rework and repair of electronic assemblies Knowledge of Labview Experience with manual/power hand tools Associates Degree in Electrical Engineering with a minimum 4-5 years of directly related experience in manufacturing testing. BS in Electrical Engineering or related discipline preferred TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
An Organ Care System (OCS) Production Test Technician II is a critical role in ensuring the reliability and safety of the OCS electrical system, including manufacturing and final test. They play a vital part in preventing electrical failures and ensuring compliance with regulatory standards. An OCS Production Test Technician II is responsible for testing, troubleshooting, and inspecting PCB Boards, Sub-Assemblies and Organ Care systems, and components to ensure they meet quality standards, safety regulations, and performance system specifications. Responsibilities
This position is responsible for, but not limited to, the following: Conduct electrical tests and Burn-IN on various components, PCB boards, sub-assemblies and Organ Care Systems to identify defects, malfunctions, or non-compliance with specifications with no non-conformances write ups. Assemble and/or Disassemble Devices per engineering documents and drawings or non-comformance's instructions. Use testing equipment (but not limited to) such as multimeters, oscilloscopes, function generators and hipot tester to measure voltage, current, resistance, and other electrical parameters. Maintain efforts to ensure all production test related activities are executed in a timely manner to satisfy Company's Production schedule and quality standards Provide training in testing and inspection methods as required. Assist Test Technicians I in all areas of testing department such as testing, troubleshooting, documentation, calibrations, efficiency, LEAN etc. Assist Engineering staff in completion of quality and regulatory activities related to product development, maintenance and/or repair. Support Engineering team and Production team efforts to identify opportunities to streamline production through Assist process, test and product design changes. Test Engineering in the troubleshooting and development of new test equipment and protocols. Support Lean, Health and Safety Initiatives. Perform other TransMedics tasks and duties as required. Troubleshooting
Perform visual inspections of electrical components and systems to identify physical damage, loose connections, or signs of wear and tear. Assist Test Engineers/Engineer Techs in the diagnose and troubleshooting of all electrical issues to determine the root cause of problems and recommend corrective actions. Analyze test data and results to identify patterns or anomalies that indicate potential issues. Repair and Maintenance
Perform basic repairs and maintenance tasks on electrical systems and equipment, such as replacing faulty components or connectors. Ensure that all monthly in-house calibration and preventative maintenance tasks on electrical systems and equipment are up to date. Ensure that all equipment and tools used for testing and maintenance are properly calibrated and in good working condition. Documentation
Maintain detailed records of test procedures, results, route sheets, and maintenance activities. Prepare test reports and documentation to report findings and provide recommendations for improvements or repairs. Initiate Non-Conforming Materials when Applicable. Safety Compliance
Adhere to safety regulations and guidelines while working with electrical systems and equipment. Ensure that all tested equipment and systems meet safety standards and requirements. Maintain individual work area and equipments in a neat orderly manner according to standards including proper disposal of packaging waste, proper storage and use of equipment and parts and management of documentation needed to perform duties. Quality Assurance
Verify that electrical systems and components meet quality standards and specifications. Collaborate with engineering and quality control teams to address any non-conformities and implement corrective actions. Work with Quality Assurance to maintain an approved internal Quality System that meets the requirements of FDA 21CFR820 and ISO 13485 standards. Comply with all work safety rules and regulations. Communication
Communicate test results, findings, and recommendations to relevant stakeholders, including engineers, supervisors, and managers. Provide technical support and guidance to other team members or technicians as needed. Perform other TransMedics tasks and duties as assigned/required. Minimum Qualifications
High school diploma or equivalent; an associate degree or certification in electrical technology or a related field with 4+ years experience. High level of proficiency in fabrication, assembly and testing required Familiarity with test equipment/procedures including but not limited to oscilloscopes, power supplies, function generators, Hipot testing and digital multimeters. Experience with testing of Printed Circuit Boards and electronic testing. Ability to follow written instructions or procedures such as mechanical assembly drawings, electrical schematics, assembly procedures, test procedures and validation procedures. Must have effective analytical and decision-making skills with a keen focus on quality and accuracy to ensure that all work assignments meet corporate quality and regulatory requirements. Must possess a strong work ethic, effective oral and written communication skills and excellent interpersonal skills. Self-starter with a strong initiative, outstanding judgment and ability to work in a fast-paced environment with demonstrated ability to adjust to changing priorities. Preferred Qualifications
Experience with IPC Standards including J-STD-001 Soldering Electrical and Electronic Components, IPC-A-610/620 PCB and Wire Harness Inspection and IPC-7711/7721 Rework and repair of electronic assemblies Knowledge of Labview Experience with manual/power hand tools Associates Degree in Electrical Engineering with a minimum 4-5 years of directly related experience in manufacturing testing. BS in Electrical Engineering or related discipline preferred TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.