Growing contract manufacturer for single use, disposable medical devices is looking for a dependable individual to join our team. The New Product Development Engineer (level I) should be a self-driven team player who has strong organizational and communication skills. This position reports to the Senior Engineering Manager.
- Lead/Assist activities associated to:
- Product specifications
- Product drawings
- Bill of materials Selection and qualification of Suppliers and their processes
- Component specifications
- Component qualifications
- Hazard and Risk Analysis documentation
- Equipment and Fixture Design
- Development of manufacturing processes and instructions
- Master Validation Plans
- Control Plans
- Manufacturing Equipment validation protocols and test reports
- Manufacturing Process validation protocols and test reports
- Packaging Process validation protocols and test reports
- Shipping and distribution validation protocols and test reports
- Sterilization Process validation protocols and test reports
- Shelf Life validation protocols and test reports
- Other Regulatory/Compliance documentation or activities as needed
- Ensure that all products/processes to be developed comply with GMPs, FDA, and other regulatory standards/guidelines as well as Phase 2 SOPs.
- Manage and prepare documentation for the transfer to manufacturing of products.
New Product Development Engineer is to be familiar with the following guidelines and procedures, as well as any related forms.
- Applicable ISO and FDA standards/guidelines
- Phase 2’s Quality Policy,Quality Manual, Assembly, Inspection, & Test Procedures SOP’s.
- BS (engineering discipline)
- 1-3 years’ experience – med device development/environment preferred
- Microsoft Suite, Project Management, CAD software
Competitive benefits offered; however, Phase 2 Medical does not offer relocation packages.
Unsolicited, Non-Contracted Agencies not subject to “finder’s fee”.