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Summary:
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
Education
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.
Education
- Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related Engineering discipline.
- Advanced degree is a plus.
- 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.
- 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
- Engineering Change Management
- Design for Manufacturability (DFM)
- Quality Systems and Design Controls
- Product Lifecycle Management (PLM)
- Medical Device Design Controls
- Engineering Change Order (ECO) processes
- Manufacturing processes
- Root Cause Analysis
- Process Improvement
- Project Management fundamentals
- Regulatory compliance (FDA, ISO 13485)
- Strong verbal and written communication skills
- Bilingual (English & Spanish)
- 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
- Continuous improvement mindset
Work Methodology:
- 100% on site job
- Full time job
- Location: Juncos, PR
- Administrative shift (willing to work Weekend when needed).
- Type of industry: Medical devices
- Expected hiring month: July 2026
- Timeframe: July 2027