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.