Material Engineer

Medial Group; Añasco (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Medial Group is seeking a Material Engineer to lead development of materials, equipment, and processes within a regulated medical device environment. The role requires planning, executing, and overseeing multiple projects while coordinating cross-functional teams.

The position demands strong problem-solving, molding experience, and hands-on validations (DOE/OQ/PQ), CAPAs, and a track record of delivering improvements with leadership and clear English communication.

Qualifications

• Bachelor’s Degree in Engineering required.
• Minimum 5 years engineering/operational experience; medical device preferred.
• Experience with molding processes preferred.
• Familiarity with validations and processing docs (DOE/OQ/PQ).
• Experience with nonconformance investigations and CAPAs.
• Experience in regulated industry (FDA environment) preferred.
• Strong analytical and problem-solving skills; risk assessment.
• Fluent in English.

Responsibilities

• Plans, conducts, and manages multiple engineering projects across various disciplines.
• Performs vendor proposal analysis and justification of capital and expense projects for project development of medium complexity.
• Develops, implements, and qualifies material, equipment, and/or process enhancements/changes that will improve product quality, yield, process sustainability, efficiency, and safety.
• Demonstrates a strong analytical approach to problem-solving to deliver innovative solutions.
• Provides project management for supplier changes to processes, systems, tools, and/or equipment at external suppliers or internal JJSV.
• Performs root cause analysis for problem-solving and improvement of manufacturing equipment, processes, and systems.
• Prepares and maintains all associated project documentation, including change management and quality system records.
• Works with agility to solve unplanned downtime or excessive rejects and proactively develops solutions to increase uptime.
• Coordinates cross-functional teams of engineers, suppliers, and technicians to achieve project completion.
• Acts as a lead in activities with internal customers and outside vendors, from design through feasibility and start-up.
• Demonstrates strong leadership and a clear, identifiable work ethos within the team.
• *Perform other duties assigned.*

Skills

Engineering experience

Molding expertise

DOE/OQ/PQ

CAPA experience

Statistical design

Six Sigma

Root-cause analysis

Leadership

Communication skills

English fluency

Independence

Project management

Education

Bachelor’s Degree in Engineering

Tools

AutoCAD

Inventor

Job description

• Industry Pharma/Biotech/Clinical Research

Job Description

The Material Engineer will perform a variety of engineering assignments utilizing a wide range of engineering principles. This role operates at a high technical expertise level, involving planning, development, and design of materials, equipment, and processes. The successful candidate will lead cross-functional initiatives, manage multiple projects, and advocate for continuous improvement in technology and processes.

Responsibilities

• Plans, conducts, and manages multiple engineering projects across various disciplines.
• Performs vendor proposal analysis and justification of capital and expense projects for project development of medium complexity.
• Develops, implements, and qualifies material, equipment, and/or process enhancements/changes that will improve product quality, yield, process sustainability, efficiency, and safety.
• Demonstrates a strong analytical approach to problem-solving to deliver innovative solutions.
• Provides project management for supplier changes to processes, systems, tools, and/or equipment at external suppliers or internal JJSV.
• Performs root cause analysis for problem-solving and improvement of manufacturing equipment, processes, and systems.
• Prepares and maintains all associated project documentation, including change management and quality system records.
• Works with agility to solve unplanned downtime or excessive rejects and proactively develops solutions to increase uptime.
• Coordinates cross-functional teams of engineers, suppliers, and technicians to achieve project completion.
• Acts as a lead in activities with internal customers and outside vendors, from design through feasibility and start-up.
• Demonstrates strong leadership and a clear, identifiable work ethos within the team.
• *Perform other duties assigned.*

Requirements

• Minimum 5 years of significant engineering and/or operational experience (medical device industry highly preferred). Experience with molding processes highly preferred.
• Experience working with validations and processing technical documents (DOE/OQ/PQ).
• Experience working with nonconformance investigations and CAPAs.
• Experience working in a regulated industry, preferably medical devices in an FDA environment.
• Experience working with suppliers is a plus.
• Proficiency in AutoCAD/Inventor.
• Relevant experience with statistical design and analysis of experiments.
• Six Sigma Green Belt/Black Belt accreditation is a plus.
• Excellent analytical and problem-solving skills, root-cause analysis, and risk assessments with strong attention to detail.
• Ability to work independently with good interpersonal and communication skills and proven leadership abilities.
• Fluent in English (spoken and written).
• Bachelor’s Degree in Engineering required.
• Flexibility to manage multiple priorities simultaneously as well as different work schedules as needed by the business.