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. This position is based in our Sandpoint, ID facility.
Essential Duties and Responsibilities:
Develop and execute verification and validation (V&V) plans, protocols, and procedures for respiratory therapy medical devices.
Collaborate with product development teams to review design inputs and outputs and ensure all V&V activities and outcomes are correctly traced to product requirements.
Execute performance, system, and product testing to ensure design inputs meet device requirements and user needs.
Work closely with design and quality teams to resolve any nonconformances identified during V&V activities.
Prepare, and maintain V&V documentation, including test protocols, test results, and validation summaries, ensuring compliance with QMS standards.
By choosing a career at Sentec, you're not just choosing a job - you're embracing the chance to make a real impact, contributing to the development of innovative medical solutions that support the wellbeing of individuals worldwide.
Sentec is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999, Sentec utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas. Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.
Bachelor's degree in engineering, biomedical engineering or related field required.
3-5 years' 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.
Experienced 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.