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.
Required Experience:
Junior IC
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