Product Engineer I

Fits, Llc; Juncos (PR); On-site; USD 45,000 - 75,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a Manufacturing Engineering support professional to bolster medical device production operations. The role emphasizes collaboration with cross-functional teams to optimize processes and ensure quality.

The candidate will provide engineering support for testing methods, device specifications, yield issues, and production optimization within cost constraints. A Bachelor's degree in engineering and bilingual English/Spanish are required, with 3rd shift and weekend

Qualifications

• Bachelor's degree in engineering and minimum of 0+ years of experience in medical device manufacturing industry.
• Bilingual English & Spanish.
• Shift: 3rd shift and weekends according to business needs.
• Preferred experience: Mechanical aptitude and manual dexterity; Computer literacy with digital tools; PLC; Vision Systems; Packaging Systems; Ultrasonic Welding; Laser Engraving.

Responsibilities

• Provide production support engineering related to testing methods, procedures, device specifications, yield issues, minor device/mask redesigns, customer returns, supplier engineering changes, and production optimization within cost constraints.
• Assume engineering responsibility for devices and internally produced or externally purchased components after transfer to high-volume production, including manufacturing operations other than wafer fabrication.
• Support customers with device usage issues and testing of complex devices, as required.
• Support the design and planning of manufacturing layouts and processes, including machining, metal forming, plastics processing, welding, brazing, assembly, and material handling.
• Support machine and equipment design, operation, and plant layout optimization to ensure efficient and productive manufacturing conditions.
• Support the design of operational sequences and fabrication procedures for tools and equipment, incorporating inspection and testing requirements into production plans when applicable.
• Inspect machinery, equipment, and tools for performance and efficiency, investigate deficiencies, and initiate corrective actions to ensure product quality.
• Ensure compliance with company procedures, applicable Quality System Regulations, standards, process requirements, and product specifications, leveraging standard engineering approaches and manufacturing techniques.
• Provide day-to-day manufacturing support and execute projects focused on scrap reduction, equipment efficiency, cost reduction, and other continuous improvement initiatives.
• Support NCMR resolution and reduction initiatives, equipment troubleshooting through resolution, and application of Lean Six Sigma concepts where applicable.
• Interpret data from multiple sources to determine appropriate courses of action, solve and elevate problems appropriately, and participate in engineering and operations meetings.
• Update documentation related to processes, validation, maintenance, and calibration, and perform/execute validations for mechanical and computer-driven equipment.

Skills

Bilingual English/Spanish

Mechanical aptitude

Manual dexterity

Computer literacy

PLC

Vision systems

Packaging systems

Ultrasonic welding

Laser engraving

Education

Bachelor's degree in engineering

Tools

PLC

Vision Systems

Packaging Systems

Ultrasonic Welding

Laser Engraving

Job description

Manufacturing engineering support for medical device production operations.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's degree in engineering and minimum of 0+ years of experience in amedical device manufacturing industry.
• Bilingual (English & Spanish).
• Shift: 3rd shift and weekends according to business needs.
• Preferred experience in:
  • Mechanical aptitude and manual dexterity
  • Computer literacy and proficiency with digital tool
  • PLC
  • Vision Systems
  • Packaging Systems
  • Ultrasonic Welding
  • Laser Engraving

The Personality Part:

• If you have excellent communication skills and aren’t afraid to ask for help when you need it (in addition to your excellent Maintenance skills), this might be the job for you! Sprinkle on a love of the scientific method, teamwork, and, above all else, being ethical, and you just might have what it takes to take on this new challenge. Bring it on!

AS A PIECE OF FITS, YOU WILL:

Key Responsibilities include but are not limited to the following:

• Provide production support engineering related to testing methods, procedures, device specifications, yield issues, minor device/mask redesigns, customer returns, supplier engineering changes, and production optimization within cost constraints.
• Assume engineering responsibility for devices and internally produced or externally purchased components after transfer to high-volume production, including manufacturing operations other than wafer fabrication.
• Support customers with device usage issues and testing of complex devices, as required.
• Support the design and planning of manufacturing layouts and processes, including machining, metal forming, plastics processing, welding, brazing, assembly, and material handling.
• Support machine and equipment design, operation, and plant layout optimization to ensure efficient and productive manufacturing conditions.
• Support the design of operational sequences and fabrication procedures for tools and equipment, incorporating inspection and testing requirements into production plans when applicable.
• Inspect machinery, equipment, and tools for performance and efficiency, investigate deficiencies, and initiate corrective actions to ensure product quality.
• Ensure compliance with company procedures, applicable Quality System Regulations, standards, process requirements, and product specifications, leveraging standard engineering approaches and manufacturing techniques.
• Provide day-to-day manufacturing support and execute projects focused on scrap reduction, equipment efficiency, cost reduction, and other continuous improvement initiatives.
• Support NCMR resolution and reduction initiatives, equipment troubleshooting through resolution, and application of Lean Six Sigma concepts where applicable.
• Interpret data from multiple sources to determine appropriate courses of action, solve and elevate problems appropriately, and participate in engineering and operations meetings.
• Update documentation related to processes, validation, maintenance, and calibration, and perform/execute validations for mechanical and computer-driven equipment.

WHO WE ARE:

We are a Service Provider companydifferent 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 industryclients with top-notch quality talent.We're FITS!

Are you the next piece?