Job Title: Manager of Design Assurance
At our organization, we are seeking a seasoned professional to fill the role of Manager of Design Assurance. This position is responsible for ensuring that product designs meet intended requirements and comply with global regulatory standards.
About the Job
This key leadership role will oversee the execution and continuous improvement of the Design Control & Risk Management processes. You will provide oversight and guidance to teams throughout the product development lifecycle, ensuring that product designs meet required standards and regulations.
Key Responsibilities
* Support the Director of Design Assurance in establishing and maintaining global policies, procedures, and principles for design control, risk management, and validation.
* Ensure the DA team consistently plans, executes, and documents the appropriate application of established procedures, processes, and principles of design controls, risk management, usability, and validation.
* Lead and mentor a team of DA engineers, focusing on resource allocation, training, and professional development to build a high-performing team that employs critical thinking to foster a culture of quality.
* Manage resources to support product launches, appropriately matching skill sets of individual direct reports to demands of projects, prioritizing efforts, anticipating technical issues, and assuring successful project outcomes.
Requirements
To be considered for this role, you must have:
* 8-12 years of experience in Quality Assurance, R&D, or related technical roles in a regulated industry.
* Minimum 2 years' experience in a QA/R&D or other technical leadership role in a regulated environment.
* Experience managing in an environment with changing priorities and making appropriate risk-based decisions in the face of uncertainty.
* Familiarity with usability engineering and design for X (DFX).
* Goal-oriented with the ability to execute on strategic initiatives and prioritize/manage deliverables.
* Strong critical thinking skills applying and cultivating new approaches to problem solving with a focus on achievement of overall project goals.
What We Offer
We offer a dynamic work environment with opportunities for professional growth and development. As a member of our team, you will receive:
* A competitive salary and benefits package.
* The opportunity to work with a talented team of professionals.
* The chance to make a meaningful contribution to the success of our organization.
About Us
We are a leading provider of healthcare products worldwide. Our mission is to make life more rewarding and dignified for people who use our products and services.