Process Engineer

Job Description

The FST Process Engineer provides engineering support for the introduction of new products; repairs and alternate repair activities (sustain engineering). Functions as a project coordinator on large and complicated projects for core products, medical software and audio/video switching projects. Creates product service specifications and instructions that promote effective, efficient, and safe technical support operations. Works with OAI staff to solve technical and quality problems. Assists with continuous improvement of overall endoscope service business.

Job Duties

• Function as Project Coordinator for implementation of new product introduction or alternate repair activities creating service instructions and other supporting documentation as well as standards development.
• Analyze project prior to implementation by benchmarking against completed projects. Plan and organize projects for successful implementation.
• Review needs of each department (e. g., Marketing, Operations, and Finance) and incorporate them into project documents.
• Develop Engineering project check list to identify start and finish dates and measure progress. Provide progress report to Engineering Supervisor or Manager and to other project participants.
• Establish and implement methods for controlling process costs. Review costs with other project members and initiate steps to control costs as needed.
• Coordinate and analyze service records and procedures in support of implementing and tracking corrective and preventive action activities (CAPA) related to RA/QA direction.
• Diagnose and troubleshoot the entire range of company electronic, video and computer-related products
• Identify parts and supplies needed to support product or process implementation and ensure they are available according to project schedules.
• Represent Field Service and TAC to provide technical guidance to the Change Control Board; educate members on technical issues associated with assigned projects.
• Train Technicians, Supervisors and other employees on use of new products or processes.
• Validate and document projects, file completed packages for use as benchmarks in subsequent projects.
• Support continuous improvement measures, by providing technical information and reviewing processes as they are revised.
• Address Change Notices (CNs) in a timely manner, to maintain project schedules and/or achieve acceptable levels of compliance.
• Support calibration and maintenance of inspection measuring and test equipment.
• Work flexible hours to ensure adequate engineering support for all shifts.
• Perform all other related duties as assigned.

Job Qualifications

Required:

• At least 3 years experience in Biomedical or IT Field or Training and /or Field Service
• Strong presentation skills required
• Ability to work flexible hours and travel by car/plane for long periods of time (including overnight travel)

Preferred:

• Associate's Degree preferred or equivalent technical expertise accepted
• Knowledge of FDA and/or ISO 13485 regulations desirable
• Knowledge of medical instrumentation/hospital equipment systems.
• Professional technical communicator preferred
• Effective technical writer ability
• Excellent written and verbal communication skills
• Able to function as a team player #Strong detail/problem solving skills
• Analytical, logical, practical thought processor
• Possess a high degree of self reliance, initiative, creativity and personal organization; able to multitask