Product Engineer

Flexible & Integrated Technical Services, LLC•Juncos, PR

7d•Onsite

About The Position

This role is for Validation services in the Manufacturing area. The ideal candidate will have a Bachelor's degree in Engineering (preferably Mechanical or Electrical) with two years of relevant experience in the Medical Devices or Pharmaceutical industry. Bilingual proficiency in Spanish and English is required, along with a proactive and task-oriented approach. The shift is administrative, and according to business needs. Experience in equipment troubleshooting, PLC knowledge, systems like Factory Works, Agile, and/or SAP, and technical documentation is essential. The company culture emphasizes treating everyone like family, prioritizing customer service, innovation, and delivering top-quality results.

Requirements

Bachelor’s degree in Engineering (preferred Mechanical or Electrical)
Two (2) years of relevant experience within the Medical Devices or Pharmaceutical industry.
Bilingual (Spanish & English).
Proactive and task-oriented.
Equipment troubleshooting and PLC knowledge.
Systems knowledge like Factory Works, Agile, and/or SAP.
Technical Documentation.

Responsibilities

Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems, minor redesign of devices and masks; analysis of customer returns; supplier related engineering changes and optimizing device production relative to cost constraints.
Assumes responsibility for device and/or internally produced or externally purchased components after transfer into high-volume production and responsible for entire device manufacturing operations other than wafer fabrication.
May assist customer in device usage problems or customer testing of complex devices.
Support design and plan of layout for activities such as machining, metal forming, plastics processing, welding and brazing, assembly, and mate handling.
Supports machine or equipment design and operation to factory and production conditions.
Supports design of arrangement of machines within plant facilities to ensure most efficient and productive layout.
Support design of sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
May incorporate inspection and test requirements into the production plan.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Complies with company programs, procedures and applicable quality system regulations and standards.
Leverages technical expertise and knowledge of Medtronic's standard engineering approaches, design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Support manufacturing in the day to day activities.
Support the execution of projects for the following disciplines (Scrap Reduction, Equipment efficiency, and Cost reduction, among others).
Support NCMR’s resolutions and NCMR reduction initiatives.
Support equipment troubleshooting until resolution applying lean sigma concepts (where applicable).
Interprets data from multiple sources to accomplish decisions towards course of action, and escalates appropriately.
Updates documentation related to process, validation, maintenance and calibrations.
Observes proper process and product specifications compliance.
Performs/Execute validations for mechanical and computer driven equipment.
Participates in engineering and operations meetings.
Solves problems as appropriate for the level of expertise.
Follows escalation process as required.