Fractyl Health · 1 day ago
Design Assurance Engineer II
Burlington, MA
Full-time
Onsite
Mid Level
$70K/yr - $90K/yr
3+ years expFractyl Health Inc is seeking a Design Assurance Engineer II to join their team. The role involves contributing to various Design Assurance responsibilities, collaborating with R&D teams on product development projects, and managing risk and complaint processes to drive product improvement.
BiotechnologyHealth CareMedical DeviceTherapeutics
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
Qualification
Required
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
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
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
Preferred
Experience with project management is a plus
Benefits
A comprehensive benefits package
Company
Fractyl Health
Fractyl Health is a biotechnology company that provides curative therapies for metabolic diseases.
51-200 employees
H1B Sponsorship
Fractyl Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$338.19MKey Investors
Taiwania Capital Management CorporationGoogle VenturesDeerfield
2025-09-26Post Ipo Equity· $60M
2025-08-05Post Ipo Equity· $23M
2024-02-02IPO
Leadership Team
Harith Rajagopalan
Co-Founder and CEO
Jay Caplan
Co-founder and President
Recent News
Longevity.Technology
2026-01-08
2026-01-06
Company data provided by crunchbase