Manufacturing Engineer – New Product Development
advitaortho · Gainesville
Job description
About the role
The New Product Development (NPD) Engineer represents Manufacturing Engineering throughout the product lifecycle. You will act as the voice of manufacturing on cross‑functional teams, ensuring designs are manufacturable, scalable, compliant, and delivered on schedule.
Key responsibilities
- Serve as the manufacturing engineering representative on new product development and sustaining project teams.
- Lead Design for Manufacturability (DFM) and Design for Assembly (DFA) activities throughout the design lifecycle.
- Review product designs, drawings, specifications, and change orders and provide formal manufacturing input.
- Define and document manufacturing processes, equipment requirements, tooling, fixtures, and work instructions for new products.
- Support or lead process validation activities (IQ/OQ/PQ) in collaboration with Quality Engineering.
- Partner with Quality to ensure compliance with FDA, ISO, and internal quality system requirements.
- Identify manufacturing risks early and drive mitigation plans for robust product launches.
- Assist pilot builds, first‑article builds, and production ramp‑up activities.
- Collaborate with Supply Chain on supplier selection, readiness, and component manufacturability.
- Provide technical support during design reviews, PFMEA, and change management.
Required profile
- Bachelor’s degree in Manufacturing, Mechanical, Biomedical, Industrial Engineering or related field.
- 1‑5 years of manufacturing engineering experience in a regulated environment (medical device, aerospace, automotive, etc.).
- Experience supporting new product development and product transfer to manufacturing.
- Demonstrated ability to apply DFM/DFA principles to product designs.
Required skills
- Design for Manufacturability (DFM) and Design for Assembly (DFA).
- Manufacturing processes, tooling, fixtures, and production equipment.
- Quality systems, process validation (IQ/OQ/PQ), and regulatory standards (FDA, ISO).
- Interpretation of engineering drawings, specifications, and GD&T.
- PFMEA and risk assessment techniques.
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Published 2 weeks ago
Expires 1 month from now
10 views · 0 interested
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advitaortho
Gainesville