Position Summary
Responsible for performing troubleshooting and investigation on field returned sequencing instrumentation and related sub-module. Work with Engineering and Quality team for corrective and preventive action. Other responsibilities include failure analysis, quality improvement, process enhancement, cost reduction, engineering evaluation and system improvement.
Responsibilities:
- Field installs compliant and escalation.
- Monitor, trend, report, and drive improvement for product field performance matrix such as Perfect Acceptance (PA) and Dead-on-Arrival (DOA).
- Drive for completion of failure analysis on returned DOA instrument within 15 days upon unit arrival in iDepot.
- Drive completion of projects that are related to PA improvement.
- As Factory liaison to engage field service & commercial teams on returned product failure analysis and resolution updates.
- Collaborate and lead cross functional teams on product return related workflows such as investigation and refurbishment.
- Lead Factory Immersion Program, understand the needs of field service and improve on the program offering.
- Establish and maintain databases of field return instrument failures and its root cause.
- Perform data trending analysis, construct and execute design of experiments to address field return failure.
- To identify risk and provide recommendations for risk mitigation in area of responsibilities.
- Drive and implement continue improvements activities.
- Provide guidance and supervision to junior staff.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
Position Requirements:
- 5 to 7 years of relevant experience.
- Good analytical and troubleshooting skills (proficiency in FMEA, 8D, 5 why and 4M1E will be added advantage).
- Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.
- Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
- Proficient in electro-mechanical and fluidics systems.
- Capable of liaising with business and product users to explain database concepts in simple terms.
- Team player with good interpersonal and communication skills.
- Independent and self-motivated.
- Able to identify components with different colors (using visual).
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities
Preferred Experience/Education/Skills:
- Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience. (Systems Engineering, Electronics, Mechanical and/or Biomedical Engineering)
- Proficient in Python, Tableau and/or Excel will be added advantage.
- Experience in statistics and data visualization will be added advantage.
- Experience with FDA regulated medical device manufacturing
