About Our Opportunity
We are seeking a Senior Quality Engineer to support our commercial projects from a Design Assurance perspective, ensuring our products comply with global standards throughout their lifecycle.
Key Responsibilities
* Sustain commercial projects by providing Design Assurance support and technical direction/input to qualification and validation activities.
* Assess patient risk for design changes and provide QA guidance on assessment and mitigation strategies.
* Generate Design Verification protocols and contribute to design verification and shelf life data for regulatory submissions, minimizing Regulatory Agency questions.
* Establish strong working relationships across the organization and with partners to drive collaboration and results.
Requirements
* Bachelor's or Master's Degree in Engineering is required; relevant experience may be considered in lieu of degree.
* 4+ years of experience in Quality/Design Assurance/R&D Engineering in the Medical Device Industry, with expertise in risk management, change management, and product/process/materials changes.
This role requires strong analytical and problem-solving skills, excellent communication and interpersonal skills, and the ability to work effectively in a fast-paced environment.