Perform lifecycle engineering initiatives including design updates, obsolescence management, cost optimizations, and performance improvements of legacy products.
Conduct the failure investigation, root cause analysis (RCA) and Corrective and Preventive Action (CAPA) processes for field issues.
Collaborate with quality, service, and reliability teams to implement corrective actions and design enhancements based on field performance data.
Support regulatory submissions and design documentation in line with FDA and EU MDR requirements.
Essential Experience & Skills
Bachelor’s or master’s degree in Mechanical/Mechatronics Engineering or related field
8+ years of experience in mechanical design of medical devices, preferably in imaging systems like X-ray, CT, IGT, Mobile Surgery or Mammography systems.
Strong proficiency in 3D CAD tools, Creo (Preferred), SolidWorks, NX etc.
Good hands-on experience in Windchill PDM/PDLM tool
Knowledge of Parametric Modeling, GD&T, Tolerance Analysis etc.
Good understanding of materials selection, thermal management, structural analysis, and ergonomics.
Experience in designing sheet metal, plastics, castings, and precision mechanical parts.
Familiarity with international standards such as IEC 60601, ISO 13485, and ISO 14971.
Experience in design control, V&V processes, and sustaining engineering activities.
Hands-on experience with prototyping, testing, and working with contract manufacturers.
Understanding of design for manufacturability (DFM), design for assembly (DFA), and design for service (DFS).
Disciplined team worker, ability to work independently.
Ability to present ideas and convince project team members.
Be structured and self-organized.
Excellent communication and articulation skills
Strong analytical and problem-solving abilities
Quality mindset in design and documentation
Desirable Experience & Skills
Exposure to EMC compliance considerations, or clinical usability standards.
Knowledge of FEA tools like ANSYS or COMSOL for mechanical simulations.
Knowledge of DFMEA, PFMEA and other Risk Management Tools
Knowledge of DOE, statistical analysis, Minitab etc.
Familiarity with agile product development and regulatory audit preparedness.
