Note: The job is a remote job and is open to candidates in USA. Sunrise Systems, Inc. is seeking a highly experienced Senior Data Scientist for a leading Medical Device Manufacturing Company. The role focuses on driving advanced analytics to improve product reliability and reduce operational risk through identifying systemic failure patterns and delivering AI-driven recommendations.
Responsibilities
- Correlate post-market data (complaints, service records, field performance) with:
- Manufacturing processes
- Supplier quality metrics
- Product design changes
- Identify emerging failure patterns and translate insights into actionable improvements
- Lead end-to-end root cause investigations using structured and unstructured data
- Apply AI/ML models, including LLMs, to enhance analysis, pattern detection, and signal identification
- Develop and deploy advanced analytics solutions, including:
- Machine learning and predictive models
- Statistical analysis frameworks
- Embedding-based similarity search
- Design and implement agentic AI workflows to automate analysis, reasoning, and recommendations
- Leverage AI models to augment decision-making and scale analytical capabilities across the organization
- Partner with R&D, Quality, Regulatory, Manufacturing, and Field Service teams to translate insights into impact
- Deliver proactive insights to support risk detection, product improvement, and operational excellence
Skills
- 7–10+ years of experience in data science, advanced analytics, or related field
- Master's degree in Data Science, Statistics, or a related discipline
- Experience in medical device or regulated manufacturing environments
- Strong understanding of FDA regulations and Quality Management Systems (QMS)
- Strong foundation in statistical modeling and hypothesis testing
- Expertise in experimental design and statistical inference (e.g., t-tests, significance testing, confidence intervals)
- Ability to select and apply appropriate statistical techniques based on problem context
- Experience with clustering (e.g., K-means), classification, and predictive modeling
- Deep expertise in machine learning and advanced analytics techniques
- Strong hands-on experience applying AI models (including LLMs) within analytical workflows
- Experience with vector embeddings and similarity search
- Ability to build and operationalize AI-driven analysis to uncover patterns and insights
- Experience designing agentic AI systems for automated reasoning, investigation, and recommendations
- Strong experience analyzing manufacturing and operational data
- Familiarity with post-market surveillance data (complaints, service data, vigilance reporting)
- Hands-on experience with SAP (Tahiti preferred), including underlying data structures
- Knowledge of SAP manufacturing and quality modules
- Understanding of product lifecycle data across design, manufacturing, and field performance
- Highly inquisitive, self-driven learner with a strong curiosity to explore complex problems
- Ability to independently define analytical strategies and select appropriate methods for different scenarios
- Strong command of hypothesis testing and statistical reasoning to validate findings
- Deep understanding of advanced statistical techniques and experimental design
- Critical thinker who can connect patterns across disparate datasets and challenge assumptions
- Proactive mindset focused on continuous learning, innovation, and improvement
- Ability to translate complex analysis into clear, actionable insights for business stakeholders
- Master's degree preferred
- Power BI
Benefits
- ACA compliant medical coverage/dental insurance/vision insurance to all employees
- Sick time benefits as required per State regulations
Company Overview