Manufacturing Engineer (All Levels), New Product Development
On-site · Gainesville, Florida, United States
Job Summary
Manufacturing Engineer for New Product Development (NPD) focusing on manufacturability, transfer to production, and compliance. Acts as the voice of manufacturing on cross-functional teams to ensure DFx, timely deliverables, and robust launches. Responsibilities include leading DFM/DFA activities, providing input on designs and change orders, defining manufacturing processes and work instructions, supporting IQ/OQ/PQ validation, ensuring FDA/ISO compliance, mitigating risks, supporting pilot and first article builds, collaborating with Supply Chain for supplier readiness, and contributing to continuous improvement; requires a Bachelor's degree in Engineering and 1-5 years in a regulated manufacturing environment, with strong technical, documentation, and cross-functional collaboration skills.
Required Qualifications
- Bachelor’s degree in Engineering (Manufacturing, Mechanical, Biomedical, Industrial, or related field) required
- Minimum 1-5 years experience in manufacturing engineering within a regulated environment (medical device, aerospace, automotive, or similar)
- Experience supporting new product development and product transfer to manufacturing
- Experience applying DFM/DFA principles to product designs
- Strong understanding of manufacturing processes, tooling, fixtures, and production equipment
- Working knowledge of quality systems, validation requirements, and regulatory standards (FDA, ISO)
- Ability to interpret engineering drawings, specifications, and GD&T
- Strong cross functional collaboration and communication skills
- Proficiency with CAD viewers, ERP/MRP, document control systems
Additional Requirements
- None specified
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