Careers that Change Lives
In this exciting role as a Sr Design Assurance Engineering Manager you will have responsibility for leading the Cardiac Surgery (CS) Design Assurance Engineering team. This includes setting and implementing the strategic direction and vision for the Design Assurance Engineering staff supporting all new product development and sustaining projects in CS. This role will also lead cross-functional strategic projects within CS and Coronary and Structural Heart (CSH) Quality.
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
- May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
- Oversees the investigation and evaluation of existing technologies.
- Guides the conceptualization of new methodologies, materials, machines, processes or products.
- Directs the development of new concepts from initial design to market release.
- Manages feasibility studies of the design to determine if capable of functioning as intended.
- Monitors documentation maintenance throughout all phases of research and development.
- Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Must Have: Minimum Requirements
- BS degree in engineering, science or technical discipline
- 7+ years of experience in product development, quality, or engineering
- 5+ years of leadership experience
Nice to Have
- 7+ years of function or program management experience within a quality function
- 7+ years as a quality professional
- Senior level knowledge of quality management, quality operations, and quality engineering industry best practices
- Knowledge and understanding of quality standards per ISO 13485, MDD, CMDR, and FDA 21 CFR 820 applicable standards
- Knowledge and understanding of the risk management process and requirements of ISO 14971
- CAPA ownership experience
- Lean Sigma experience
- DRM Certified