Job Description
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
Key skill Required
- Attention to Detail
- Biomedical Engineering
- Communication
- Compliance
- Continuous Monitoring
- Design
- Design Requirements
- Development
- Documentation
- Healthcare
- Influence
- ISO 13485
- ISO 14971
- Management
- Medical Device
- Product Development
- Product Testing
- Professional Growth
- Regulatory Standards
- Reimbursement
- Respiratory Care
- Respiratory Therapy
- Risk Management
- Science
- Test Protocols
- Therapy
- Validation
- Verification and Validation
- Work Independently
- Written Communication