Design and implement end-to-end data solutions to support the authoring, management, and analysis of product development and regulatory documentation
Develop and deploy AI-driven tools to automate and enhance product development workflows and lifecycle processes
Build intuitive data visualizations and dashboards to communicate complex insights to cross-functional stakeholders
Collaborate with business and technical partners to identify opportunities for data science, automation, and digital transformation across product lifecycle activities
Support and enhance data integration pipelines, ensuring data quality, accessibility, and compliance
Promote and enable adoption of digital tools and AI capabilities across the organization through collaboration, training, and documentation
Develop and create data products for the authoring and development of regulatory fillings
Develop, train, and support cross-functional teams in using digital tools and data products, ensuring effective adoption and long-term value creation
Collaborate with stakeholders to gather requirements, create user stories, and develop business cases that clearly articulate the value and benefits of digital solutions and data-driven approaches
Operate autonomously to drive stakeholder engagement, promoting the adoption of new technologies and data products to enhance the combination product lifecycle
Requirements
High school diploma / GED and 10 years of Engineering experience OR Associate’s degree and 8 years of Engineering experience OR Bachelor’s degree and 4 years of Engineering experience OR Master’s degree and 2 years of Engineering experience OR Doctorate degree
Advance Degree in Engineering (Mechanical, Biomedical, or Chemical)
A minimum of 3 years of experience working in a regulated environment, ensuring compliance with 21 CFR 820 and MDR
A minimum of 3 years of experience in data analytics, including the use of data and statistical methods
Experience designing and deploying data solutions across the full stack—from data centric solution from ingestion and transformation to analytics and visualization
Strong proficiency in scripting language like Python and Query Languages like SQL
Demonstrated expertise with coding and/or AI platforms, including tools like ChatGPT
Knowledge of statistical analysis, data visualization, and basic machine learning or AI concepts
Experience leading technical teams, including prioritizing tasks and managing resources
Strong knowledge of device regulatory requirements, medical device development, engineering processes, and design controls
Experience in developing and executing design plans, protocols, reports, and risk assessments for medical devices
Understanding of Six Sigma methodologies and application of statistical tools for problem-solving
Excellent written and verbal communication skills, with the ability to thrive in a highly matrixed team environment
Benefits
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
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