Junior Quality Engineer Failure Investigations

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profile Job Location:

Manchester, CT - USA

profile Monthly Salary: Not Disclosed
Posted on: 2 days ago
Vacancies: 1 Vacancy

Job Summary

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 FDAs 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 DEKAs 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.


Required Experience:

Junior IC

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...
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About Company

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DEKA Research and Development is perhaps best known for its founder and president Dean Kamen -- and for the Segway Personal Transporter he invented. DEKA is a design and engineering firm that develops innovative technologies, many of them in the field of medical devices. The Segway it ... View more

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