Design Assurance Engineer II

<p><strong>Position Summary</strong></p> <p>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.</p> <p><strong>Primary Responsibilities</strong></p> <ul> <li>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.</li> <li>Work with cross-functional complaint teams to conduct product malfunction investigations and root cause analysis to drive product improvement.</li> <li>Assist with monthly and weekly complaint metrics and analysis. Assist with data analysis, visualization, and reporting using MS Excel and Tableau.</li> <li>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</li> <li>Execute corrective actions to solve problems and non-conformances based on root cause analysis.</li> <li>Assist with the review of document and design changes.</li> <li>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.</li> </ul> <p><strong>Education or Certification Requirements</strong></p> <ul> <li>Bachelor's degree in engineering, science, or related field</li> </ul> <h4>Experience, Qualifications, and Skills</h4> <ul> <li>Minimum of 3-5 years of experience in design assurance/engineering roles within the medical device industry.</li> <li>Experience with risk management methodologies (e.g., FMEA, fault tree analysis) and risk management tools.</li> </ul> <ul> <li>Solid computer skills essential, including Microsoft Office Suite, Adobe, Minitab, etc.</li> <li>Comfortable with basic statistics and data analysis</li> <li>Knowledge of FDA regulations and ISO 13485 standards for medical devices</li> <li>Experience with project management is a plus</li> </ul> <p><strong>Other Essentials and Key Success Factors</strong></p> <ul> <li>Strong analytical and problem-solving skills</li> <li>Strong attention to detail and ability to prioritize tasks with a passion to deliver quality results</li> <li>Ability to lead fast-paced projects</li> <li>Proven and successful track record as a team-player and collaborator in small working environments</li> <li>Excellent verbal and written communication skills</li> <li>Highest levels of professionalism, personal values and ethical standards</li> </ul> <h4>Compensation</h4> <p>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.</p> <p><strong>The description and requirements outlined above are general; additional requirements may apply.</strong></p> <p> </p> <p><strong>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.</strong></p> <p> </p> <h4> </h4> <p> </p> <section class="b_paragraph" data-md-index="7" data-bm="101"></section> <section class="b_paragraph" data-md-index="8" data-bm="102"></section>