Senior Quality Engineer defining and executing quality strategies for AI - driven products. Collaborating on data engineering and application development for product reliability and user experience.
About the role
- Product Safety Quality Engineer evaluating product safety and compliance in hospital patient monitoring devices. Utilizing risk analysis methodologies and regulatory standards for quality assurance in medical devices.
Responsibilities
- Evaluates product designs to uncover safety concerns and potential hazards.
- Applies advanced risk assessment tools, including Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA), during the assessment process.
- Perform comprehensive reviews to ensure product safety is thoroughly addressed.
- Identifies and documents risks that could impact reliability and compliance.
- Uses systematic methodologies to analyze and mitigate potential safety issues in hospital patient monitoring products.
Requirements
- 2+ years of experience with Bachelor’s OR some experience with Master’s in areas such as DFMEA’s, product quality, and risk management analysis and documentation activities in the medical device industry; 5+ years strongly preferred.
- strong knowledge of relevant regulations and standards (ISO 13485, 14971; IEC 62304, 82304, etc.)
- strong knowledge of FMEA’s, and risk management related activities, Design for Quality (DFQ), and root cause analysis methods.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
- Excellent communicator, with an ability to influence cross-functional stakeholders utilizing your technical expertise and knowledge of risk management best practices.
Benefits
- generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
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