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...
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.
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
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