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 analysis

Root Cause Analysis:

Structured, data-driven problem solving using inductive/deductive reasoning

Risk 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 actions

Analytical Skills:

Ability to interpret complex or ambiguous data and identify meaningful patterns

Self-Management:

Ability to manage multiple investigations and prioritize effectively

Technical Communication:

Clear, concise documentation of investigations and findings As 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 actions Participate actively in multidisciplinary investigation teams, bringing quality and accuracy to technical discussions Analyze field return data, failure modes, and trends to identify systemic issues and improvement opportunities Interpret investigation results and translate findings into actionable recommendations for design, manufacturing, or process improvements Ensure investigation findings are properly documented and integrated into the risk management file Attain and maintain comprehensive understanding of device design, manufacturing processes, and core technologies to support effective investigation Peer review investigation reports to ensure accuracy and completeness Contribute to continuous improvement initiatives based on investigation insights To be successful in this role, you will need the following skills: BS/MS in Science or Engineering Hands-on experience troubleshooting electromechanical products and systems Experience with electronics test equipment (multi-meters, oscilloscopes, power supplies, microscopes) Strong data analysis and problem-solving skills Excellent written and verbal communication skills Must have strong attention to detail Nice to have skills: Experience with medical device field returns and complaint handling Ability to read and interpret electrical schematics and mechanical drawings Familiarity with statistical analysis tools (Minitab, JMP, etc.) Experience with electromechanical device development Knowledge 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. Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.