Senior Quality Engineer Role
This permanent hybrid position offers a unique opportunity to work with collaborative partners who drive continuous improvement through cross-functional relationships.
* Goal-oriented professionals who focus on customer needs and deliver safe, robust solutions.
* Motivated product launchers who bring strategic direction and execution to ensure products are developed and launched with precision.
Responsibilities:
1. Influence engineering and operations to define design requirements and develop manufacturing processes.
2. Drive reliability engineering, human factors engineering, risk management, and design validation while ensuring compliance with quality systems.
3. Develop quality assurance documentation to support new product development and regulatory submissions.
4. Guide new product development teams through internal quality system requirements.
5. Lead risk management for new development products, including risk analysis and mitigation strategies.
6. Evaluate residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
7. Engage in design reviews by identifying risks associated with products used and tracking mitigation throughout development.
Requirements:
* Bachelor's degree in science, engineering, or a related field.
* A minimum of 2+ years of experience in technical engineering or quality engineering within an R&D or manufacturing environment.
* Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.