software assessor ( Medical standards)TÜV Süd
Workplace: MetroManila, Manila, Pasig
Salary: Agreement
Work form: Full time
Posting Date: 19/04/2024
Deadline: 25/12/2023
Job Description:
Your Tasks
Software Assessor (Medical Standards)
The expert is responsible for assessing the safety and performance of medical device in aspects of software to ensure that manufacturers comply with relevant regulations and standards.
Key Responsibilities:
Deep understanding of technical documentation requirements for software-enabled medical devices, including but not limited to software specifications, design and architecture documents, risk management files, and software validation plans
Ensuring that the various phases of the software development lifecycle and the corresponding documentation needs for each phase in software-enabled medical devices are carried out
Assessing software development life cycle process to align with best practices
Evaluating risk management files for software-enabled medical devices, including risk analysis, risk evaluation, and risk control measures to ensure appropriate identification, assessment, and mitigation of risks throughout the product lifecycle
Key Requirements:
Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field
At least 2 years of experience in a TIC related industry and/or software testing (this includes the time for the Bachelor, Master or PHD Thesis)
Any knowledge in relevant standards governing medical devices, especially those related to software, such as IEC 62304, IEC 82304-1, will be preferred
Any knowledge on Standards and regulations such as ISO 13485, and EU Medical Device Regulation (MDR) will be an advantage
Strong technical writing abilities to provide clear and concise feedback on the technical documentation and communicate assessment findings effectively
Excellent communication and interpersonal skills to collaborate effectively with manufacturers and other team members in English language. Ability to articulate assessment findings clearly and professionally
The ability to work independently and as part of a team and under pressure to meet deadlines and maintain confidentiality
Your Qualifications
Additional Information
Required Experience:
Professionals 3 - 5 years of experience
TÜV SÜD
Your Tasks
Software Assessor (Medical Standards)
The expert is responsible for assessing the safety and performance of medical device in aspects of software to ensure that manufacturers comply with relevant regulations and standards.
Key Responsibilities:
Deep understanding of technical documentation requirements for software-enabled medical devices, including but not limited to software specifications, design and architecture documents, risk management files, and software validation plans
Ensuring that the various phases of the software development lifecycle and the corresponding documentation needs for each phase in software-enabled medical devices are carried out
Assessing software development life cycle process to align with best practices
Evaluating risk management files for software-enabled medical devices, including risk analysis, risk evaluation, and risk control measures to ensure appropriate identification, assessment, and mitigation of risks throughout the product lifecycle
Key Requirements:
Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field
At least 2 years of experience in a TIC related industry and/or software testing (this includes the time for the Bachelor, Master or PHD Thesis)
Any knowledge in relevant standards governing medical devices, especially those related to software, such as IEC 62304, IEC 82304-1, will be preferred
Any knowledge on Standards and regulations such as ISO 13485, and EU Medical Device Regulation (MDR) will be an advantage
Strong technical writing abilities to provide clear and concise feedback on the technical documentation and communicate assessment findings effectively
Excellent communication and interpersonal skills to collaborate effectively with manufacturers and other team members in English language. Ability to articulate assessment findings clearly and professionally
The ability to work independently and as part of a team and under pressure to meet deadlines and maintain confidentiality
Your Qualifications
Additional Information
Required Experience:
Professionals 3 - 5 years of experience
TÜV SÜD
Other Info
Pasig City, Metro Manila
Permanent
Full-time
Permanent
Full-time
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TÜV Süd
About the company
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