Verification & Validation Engineer

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.

Requirements

Qualifications/ Education:

• 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.

Benefits

• Meaningful work in a rapidly growing company with opportunity for advancement
• Directly influence the quality of products and make a difference for patients worldwide
• Opportunities for professional and personal growth
• Salary: $85,000-$100,00 plus bonus

Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave , a wellness stipend and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth. Sentec focuses on delivering impactful healthcare products and improving patient care.

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.

Sentecis 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.

Qualification

Bachelor's Degree