Product Engineer

FITS, LLC; Juncos (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

FITS, LLC is seeking a proactive individual for production support engineering in Juncos, Puerto Rico. You will handle device specification and manufacturing operations, assist in troubleshooting, and engage in customer support for device usage. The ideal candidate is bilingual in Spanish and English, holds a Bachelor's degree in Engineering, and has relevant experience in the Medical Devices or Pharmaceutical industry. Join a flexible and family-oriented environment focused on employee well-being.

Qualifications

• Bachelor's degree in Engineering (mechanical or electrical) and 2 years experience in Medical Devices or Pharmaceutical industry.
• Bilingual (Spanish and English) required.
• Proactive and task-oriented approach.

Responsibilities

• Responsible for production support engineering and device specification.
• Assist customers in device usage problems or testing of devices.
• Support design and plan layout for manufacturing activities.

Skills

Bilingual (Spanish & English)

Proactive

Task-oriented

Equipment troubleshooting

PLC knowledge

Technical Documentation

Education

Bachelor’s degree in Engineering (Mechanical or Electrical preferred)

Tools

Factory Works

Agile

SAP

Job description

Validation Services – Manufacturing Area

What Makes You a Fit

The Technical Part

• 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).
• Skills: Proactive and task-oriented.
• Shift: Administrative, and according to business needs.
• Experience in:
  • Equipment troubleshooting and PLC knowledge.
  • Systems knowledge like Factory Works, Agile, and/or SAP.
  • Technical Documentation.

The Personality Part

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

As a Piece of Fits, You Will:

• 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.

Who We Are:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well‑being while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top‑notch quality talent.

We’re FITS! Are you the Next Piece?