Design Assurance Engineer II

Position Summary

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.

Primary Responsibilities

• 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.

Education or Certification Requirements

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

Experience, Qualifications, and Skills

• 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.

• Solid computer skills essential, including Microsoft Office Suite, Adobe, Minitab, etc.
• 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

Other Essentials and Key Success Factors

• 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

Compensation

This position offers a competitive salary in the range of $62,000 – $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.

In accordance with Massachusetts law, General Laws Chapter 149, Section 19B. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.