Associate Sustaining Engineer - job 1 of 2

Position Summary

• Helps in working with key suppliers to identify and develop improvements to ensure quality and cost requirements.
• Assists and may lead component qualification activities and improvements.
• Helps in developing fixtures, jigs and gages to assist with component inspection processes.
• Documents methods for inspection processes; assists in TMV activities.
• Log evaluations into Engineering Notebooks
• Assists in the design, evaluation, implementation, monitoring and operating systems for the manufacture of aortic stent grafts and delivery systems.
• Helps to develop and implement new Mfg. processes, execute process validations such as IQ, OQ, PQ protocols and reports.
• Conducts risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
• Supports the conversion of small-scale processes into commercially viable large-scale operations.
• Works with Research and Development to develop and transfer new component designs to manufacturing.
• Perform statistical analyses on data groups.
• Presents data and projects to upper management when required.
• Helps perform TMV and software validation activities as necessary.
• Monitors and helps improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
• Supports Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc.
• Other various responsibilities and projects, as necessary

This position requires cooperating with different company departments, such as Quality, R&D, Regulatory, Operations, Sales, Marketing, Finance and the other team members of the department.

Minimum Skills and Capabilities:

• Must work well under pressure.
• Knowledge of AutoCAD and SolidWorks
• Knowledge of engineering statistics
• Technical writing skills for manufacturing instructions, test methods, protocols, reports, etc. a must
• Able to work closely with a variety of people and teams within the company.
• Ability to organize and conduct experiments independently.
• Ability to analyze and solve technical problems.
• Hands on abilities to engineer tooling, processes, and equipment.
• Hands on experience building prototypes, tooling, and fixtures.
• Excellent written and verbal communication skills
• Proficient in software applications

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree in engineering or a 2 - year technical degree with equivalent experience
  • Experience in a technical role within the medical device industry preferred.