Product Development Engineer

Medial Group; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Medial Group in Juncos, Puerto Rico, is seeking a Product Development Engineer to support design, development, and continuous improvement of medical device products. You will implement engineering changes, maintain design documentation, and ensure compliance with quality and regulatory requirements.

The role collaborates with Engineering, Manufacturing, Quality, Planning, and Materials to drive design solutions that improve performance, manufacturability, and efficiency.

Qualifications

• Minimum of 2 years of engineering experience in product development or manufacturing engineering.
• Experience in regulated industries such as Medical Device, Pharmaceutical, or Life Sciences preferred.
• Experience managing engineering changes and design documentation.

Responsibilities

• Support product design, development, and engineering change activities throughout the product lifecycle.
• Prepare and maintain engineering documentation, specifications, and technical records in accordance with company quality standards.
• Initiate and process engineering change documentation, including PCH, RCH, DCH, QCH, MCS.
• Collaborate with Product Development, Manufacturing, Quality, Materials, Tooling, and Planning teams to ensure design feasibility and manufacturability.
• Modify existing product designs and components to improve functionality, manufacturing efficiency, and field performance.

Skills

Strong communication

Analytical skills

Problem-solving

Organizational skills

Independent work

Cross-functional collaboration

Leadership coaching

Education

Bachelor's degree in Mechanical, Biomedical, Industrial Engineering or related field

Advanced degree (preferred)

Tools

Agile MAP/PLM

SAP

Design Control Systems

CAD software

Quality Systems

DFM

Job description

Juncos, Puerto Rico

The Product Development Engineer supports the design, development, and continuous improvement of medical device products by implementing engineering changes, maintaining design documentation, and ensuring compliance with quality and regulatory requirements. This role collaborates with cross-functional teams including Engineering, Manufacturing, Quality, Planning, and Materials to develop design solutions that improve product performance, manufacturability, and operational efficiency.

Responsibilities

• Support product design, development, and engineering change activities throughout the product lifecycle.
• Prepare and maintain engineering documentation, specifications, and technical records in accordance with company quality standards.

Initiate and process engineering change documentation, including:

• Product Change Notices (PCH)
• Revision Change Notices (RCH)
• Design Change Notices (DCH)
• Quality Change Notices (QCH)
• Manufacturing Change Specifications (MCS)
• Execute engineering changes using Agile MAP, SAP, and Design Control systems.
• Review product development requirements to ensure compatibility with manufacturing processes and product design outputs.
• Collaborate with Product Development, Manufacturing, Quality, Materials, Tooling, and Planning teams to ensure design feasibility and manufacturability.
• Modify existing product designs and components to improve product functionality, manufacturing efficiency, and field performance.
• Develop and maintain CAD models, drawings, and engineering documentation using approved design software.
• Coordinate design requirements with cross-functional teams to optimize manufacturing processes, material availability, tooling, and contractual requirements.
• Ensure engineering documentation and product development activities comply with applicable quality systems and regulatory standards.
• Identify opportunities for process improvements and recommend solutions to enhance engineering efficiency and product quality.
• Participate in technical projects and support new product development initiatives.
• Provide technical guidance and mentoring to junior engineers when required.
• Support project execution while meeting timelines, quality objectives, and business priorities.

Requirements

Education

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related Engineering discipline.
• Advanced degree is a plus.

Experience

• Minimum of 2 years of engineering experience in product development, design engineering, or manufacturing engineering.
• Experience in regulated industries such as Medical Device, Pharmaceutical, or Life Sciences preferred.
• Experience managing engineering changes and design documentation.

Required Technical Skills

• Agile MAP / Product Lifecycle Management (PLM)
• SAP
• Design Control Systems
• CAD software (SolidWorks, CATIA, Creo/ProEngineer, Siemens NX, AutoCAD, or similar)
• Engineering documentation and technical specifications
• Product Design & Development
• Design for Manufacturability (DFM)
• Quality Systems and Design Controls

Preferred Knowledge

• Product Lifecycle Management (PLM)
• Medical Device Design Controls
• Manufacturing processes
• Process Improvement
• Regulatory compliance (FDA, ISO 13485)

Soft Skills

• Strong verbal and written communication skills
• Excellent analytical and problem-solving skills
• Strong organizational and documentation abilities
• Quality-focused mindset
• Ability to work independently with minimal supervision
• Cross-functional collaboration and teamwork
• Ability to manage multiple priorities in a fast-paced environment
• Leadership, coaching, and mentoring skills