Senior Design Assurance Engineer
Nextern, a medical device design and manufacturer, is seeking a Senior Design Assurance Engineer. Nextern focuses on medical devices in markets utilizing endovascular therapy delivery and electro-mechanical integrated systems.
Be a key contributor to the Nextern product realization team, a talented group of dedicated engineering professionals who work together to solve problems, reach goals and deliver products that exceed customer expectations. Join an organization with a passion for creating smart, intuitive and effective, medical products.
The Senior Design Assurance Engineer utilizes risk management and quality planning activities to provide quality engineering support of medical device design and development activities. The Senior Design Assurance Engineer provides leadership on championing departmental or cross-functional design assurance initiatives and acts as an effective leader or team member in supporting quality disciplines, decisions and practices.
- BS or advanced degree in engineering or related discipline
- 5+ years overall design assurance and medical device experience
- Experience with software design assurance is preferred
- Experience with Quality Systems as outlined in CFR820/ ISO13485
- Experience with Risk management as outlined in ISO 14971
- Preferred experience working within the requirements of: IEC 62304, ISO 62366, and IEC 60601
- Demonstrated technical expertise and leadership in quality
- Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
- Demonstrated use of Quality tools and methodologies
- High attention to detail, organization and accuracy
- Fitness Center Subsidy