What are the responsibilities and job description for the Validation Engineer position at Sentec?
The Verification & Validation Engineer is responsible for ensuring medical devices meet design requirements by developing and executing tests to verify product functionality and performance.
This role involves collaborating with cross-functional teams to ensure compliance with medical device quality and regulatory standards.
Key responsibilities include:
Developing and executing verification and validation plans, protocols, and procedures for respiratory therapy medical devices.
Collaborating with product development teams to review design inputs and outputs and ensure all V&V activities and outcomes are correctly traced to product requirements.
Executing performance, system, and product testing to ensure design inputs meet device requirements and user needs.
Working closely with design and quality teams to resolve any nonconformances identified during V&V activities.
Preparing and maintaining V&V documentation, including test protocols, test results, and validation summaries, ensuring compliance with QMS standards.
About Sentec
Sentec is a Swiss-American medical device company specializing in respiratory care. We utilize a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas. Our mission is to provide healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.
We are seeking a skilled Verification & Validation Engineer to join our team. The ideal candidate will have:
A bachelor's degree in engineering, biomedical engineering, or a related field.
3-5 years of experience working in V&V activities for medical devices.
Strong knowledge of medical device regulatory standards such as ISO 13485, ISO 10993, FDA 21 CFR Part 820, IEC 60601.
Experience with risk management methodologies, including FMEA and ISO 14971.
Strong verbal and written communication skills with the ability to communicate with colleagues of various cultures and personalities across internal and external teams.
Possess an analytical mindset, strong attention to detail, and be able to work independently.
This role involves collaborating with cross-functional teams to ensure compliance with medical device quality and regulatory standards.
Key responsibilities include:
Developing and executing verification and validation plans, protocols, and procedures for respiratory therapy medical devices.
Collaborating with product development teams to review design inputs and outputs and ensure all V&V activities and outcomes are correctly traced to product requirements.
Executing performance, system, and product testing to ensure design inputs meet device requirements and user needs.
Working closely with design and quality teams to resolve any nonconformances identified during V&V activities.
Preparing and maintaining V&V documentation, including test protocols, test results, and validation summaries, ensuring compliance with QMS standards.
About Sentec
Sentec is a Swiss-American medical device company specializing in respiratory care. We utilize a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas. Our mission is to provide healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.
We are seeking a skilled Verification & Validation Engineer to join our team. The ideal candidate will have:
A bachelor's degree in engineering, biomedical engineering, or a related field.
3-5 years of experience working in V&V activities for medical devices.
Strong knowledge of medical device regulatory standards such as ISO 13485, ISO 10993, FDA 21 CFR Part 820, IEC 60601.
Experience with risk management methodologies, including FMEA and ISO 14971.
Strong verbal and written communication skills with the ability to communicate with colleagues of various cultures and personalities across internal and external teams.
Possess an analytical mindset, strong attention to detail, and be able to work independently.
