Design Assurance Engineer II

We are seeking a Design Assurance Engineer II to join our team. The ideal candidate is a talented individual who is enthusiastic about learning while making a difference in the world. The DA Engineer will have the opportunity to contribute to a variety of Design Assurance core responsibilities, being the key QA team member on one or more product development projects, working collaboratively with the R&D teams from concept generation through manufacturing transfer, and contributing to risk management process throughout.

The role also includes directing cross-functional complaint teams on investigations and root cause analysis to drive product improvement, assisting with complaint metrics and analysis, development of automated metrics system, and managing CAPAs, as required.

• Contribute to new product development activity by participating in Design Assurance tasks including risk management activities, V&V planning and execution, statistical analysis, design reviews, and R&D testing.
• Work with cross-functional complaint teams to conduct product malfunction investigations and root cause analysis to drive product improvement.
• Assist with monthly and weekly complaint metrics and analysis. Assist with data analysis, visualization, and reporting using MS Excel and Tableau.
• Assist with the management of the corrective and preventive action system by leading teams through the process, facilitating structured root cause analysis, and keeping CAPAs on track to target timelines
• Execute corrective actions to solve problems and non-conformances based on root cause analysis.
• Assist with the review of document and design changes.
• Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.

• Bachelor's degree in engineering, science, or related field

• Minimum of 3-5 years of experience in design assurance/engineering roles within the medical device industry.
• Experience with risk management methodologies (e.g., FMEA, fault tree analysis) and risk management tools.
• Comfortable with basic statistics and data analysis
• Knowledge of FDA regulations and ISO 13485 standards for medical devices
• Experience with project management is a plus

• Strong analytical and problem-solving skills
• Strong attention to detail and ability to prioritize tasks with a passion to deliver quality results
• Ability to lead fast-paced projects
• Proven and successful track record as a team-player and collaborator in small working environments
• Excellent verbal and written communication skills
• Highest levels of professionalism, personal values and ethical standards

This position offers a competitive salary in the range of $70,000 – $90,000 annually, along with a comprehensive benefits package. Actual compensation will be based on relevant experience, education, and market factors.

The description and requirements outlined above are general; additional requirements may apply.