Product Development Engineer
Our client is a medical device company located near the Princeton, NJ area.
- Work closely with the R&D, Manufacturing, Quality departments and Outside Vendors in the implementation and documentation for design transfer.
- Shepherd product development process through idea/concept, design, prototyping, development, testing design verification/validation, and manufacturing.
- Design, develop, and test processes for producing prototypes and long-term production of products
- Define quality control criteria and safety guidelines
- Test products and processes and evaluate results to identify problems and mitigation strategies
- Assist in writing/revising SOPs, validation/verification reports, and other design control required documents, ensuring they meet company and regulatory body standards.
- Document the transfer of technology from R&D to Manufacturing
- Use company's document and quality system to document essentials for the entire development process
- Work closely with team to develop cost estimates
- Bachelor's degree in Engineering (Chemical Engineering preferred) or related disciplines
- Minimum 1 year experience in Product Development Engineering disciplines essential
- Experience in pharmaceutical, biopharmaceutical, biotech, healthcare or medical device businesses highly preferred
- Experience in a GMP environment required
- Documentation experience highly preferred
- Strong writing and verbal communication skills essential
Bachelor's degree in Engineering (Chemical Engineer preferred) or related disciplines
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