Product Development Engineer
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Job Summary
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)
- Product Change Notices (PCH)
- 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
- Bachelors 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
- Engineering Change Management
- Design for Manufacturability (DFM)
- Quality Systems and Design Controls
Preferred Knowledge
- 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)
Soft Skills
- 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
Required Skills:
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 Engineering Change Management Design for Manufacturability (DFM) Quality Systems and Design Controls Preferred Knowledge 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) Soft Skills 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
Required Education:
Bachelors Degree in Mechanical Engineering Biomedical Engineering Industrial Engineering or a related Engineering degree is a plus.
