What are the responsibilities and job description for the Respiratory Device Validation Specialist position at Sentec?
About Us:
Sentec is a Swiss-American medical device company specializing in respiratory care. Our mission is to provide innovative solutions that support the well-being of individuals worldwide.
Our Team:
- We're a team of passionate professionals dedicated to developing high-quality medical devices.
- We work closely with cross-functional teams to ensure compliance with medical device quality and regulatory standards.
The Role:
We're seeking an experienced Verification & Validation Engineer to join our team. As a key member of our product development team, you'll be responsible for ensuring medical devices meet design requirements by developing and executing tests to verify product functionality and performance.
Key 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.
Requirements:
- 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.
