- Technical Expertise: Strong ability to comprehend complex electromechanical systems and apply engineering principles to failure analysis. Solid engineering foundation with practical problem-solving skills.
- Investigative Mindset: Natural curiosity and systematic approach to uncovering root causes through data analysis, inductive and deductive reasoning, and structured problem-solving methodologies.
- Risk Management Acumen: Understanding of how failure modes relate to product risks and ability to translate investigation findings into risk file updates.
- Project Leadership: Skilled in managing investigation timelines, coordinating with multiple stakeholders, and driving investigations to closure with actionable outcomes.
- Collaboration: Effectively lead cross-functional investigation teams, facilitate discussions, and build consensus around root cause and corrective actions. Foster a supportive and productive investigation environment.
- Analytical Thinking: Ability to synthesize complex technical data, identify patterns, and draw sound conclusions from incomplete or ambiguous information.
- Effective Communication: Ability to present investigation findings clearly and persuasively to diverse audiences, from technicians to senior leadership, adapting technical depth appropriately.
- Self-Motivated: Able to independently manage multiple concurrent investigations, prioritize effectively, and maintain momentum without constant oversight.
- Technical Writing: Proficient in documenting investigation reports, root cause analyses, and technical summaries with clarity, precision, and appropriate detail.
- Lead and support 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 regulatory perspective 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 in accordance with ISO 14971:2019
- Evaluate failure modes against existing risk analyses (FMEAs, Risk Analysis) and identify when risk file updates are warranted
- Attain and maintain comprehensive understanding of device design, manufacturing processes, and core technologies to support effective investigation
- Utilize structured problem-solving methodologies (e.g., 5 Whys, Ishikawa diagrams, Fault Tree Analysis) to systematically identify root causes
- Review and approve investigation reports to ensure accuracy, completeness, and regulatory compliance
- Provide guidance on QMS, FDA Part 820, and ISO 13485 compliance as it relates to investigations and corrective actions
- Collaborate with design, manufacturing, and test teams to implement and verify corrective actions
- Contribute to continuous improvement initiatives based on investigation insights
- BS/MS in Science or Engineering
- 3-5 years' experience in quality engineering, failure analysis, or related role in a regulated environment
- Demonstrated experience leading or supporting root cause investigations
- Strong understanding of failure analysis methodologies and problem-solving tools
- Knowledge of FDA's Quality System Regulation (21 CFR Part 820)
- Knowledge of ISO 13485 and related quality standards
- Experience with Risk Management principles (ISO 14971)
- Experience with Corrective and Preventive Action (CAPA) processes
- Strong data analysis and interpretation skills
- Excellent written and verbal communication skills
- Proficient in data analysis and documentation tools, including Excel, Word, Visio, and statistical analysis software.
- Experience with medical device field returns and complaint handling
- Knowledge of ISO 10993 (biocompatibility) and other product testing standards
- Experience with Design for Reliability (DFR) principles
- Familiarity with statistical analysis tools (Minitab, JMP, etc.)
- Experience with electromechanical device development
- Six Sigma or other formal problem-solving certification (Green Belt, Black Belt)
- Experience interfacing with regulatory bodies or participating in audits
Top Skills
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
