Junior Quality Engineer - Failure Investigations

Join our dynamic team at DEKA and help solve complex technical challenges in subcutaneous drug delivery systems. As a Junior Quality Engineer focused on Failure Investigations, you will play a key role in a collaborative environment, supporting root cause investigations and driving product improvements through systematic analysis. This is a high-visibility role with direct impact on product quality, safety, and overall program success.As a key contributor to our team, the following skills are required:Technical Expertise: Ability to understand complex electromechanical systems and apply engineering principles to failure analysisRoot Cause Analysis: Structured, data-driven problem solving using inductive/deductive reasoningRisk Awareness: Understanding of failure modes and their impact on product risk (e.g., risk file integration)Collaboration: Effective cross-functional communication and ability to drive alignment on root cause and corrective actionsAnalytical Skills: Ability to interpret complex or ambiguous data and identify meaningful patternsSelf-Management: Ability to manage multiple investigations and prioritize effectivelyTechnical Communication: Clear, concise documentation of investigations and findingsAs a Quality Engineer, you will contribute in the following areas:Conduct multiple simultaneous field return investigations from initiation through closure, ensuring thorough root cause analysis and appropriate corrective actionsParticipate actively in multidisciplinary investigation teams, bringing quality and accuracy to technical discussionsAnalyze field return data, failure modes, and trends to identify systemic issues and improvement opportunitiesInterpret investigation results and translate findings into actionable recommendations for design, manufacturing, or process improvementsEnsure investigation findings are properly documented and integrated into the risk management fileAttain and maintain comprehensive understanding of device design, manufacturing processes, and core technologies to support effective investigationPeer review investigation reports to ensure accuracy and completenessContribute to continuous improvement initiatives based on investigation insightsTo be successful in this role, you will need the following skills:BS/MS in Science or EngineeringHands-on experience troubleshooting electromechanical products and systemsExperience with electronics test equipment (multi-meters, oscilloscopes, power supplies, microscopes)Strong data analysis and problem-solving skillsExcellent written and verbal communication skillsMust have strong attention to detailNice to have skills:Experience with medical device field returns and complaint handlingAbility to read and interpret electrical schematics and mechanical drawingsFamiliarity with statistical analysis tools (Minitab, JMP, etc.)Experience with electromechanical device developmentKnowledge of FDA's Quality System Regulation (21 CFR Part 820), ISO 13485 or (ISO 14971)About DEKA:One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.