New Product Development Engineer (Direct Hire)Madison, WIJob Requisition: 6782
Description for New Product Development Engineer:
The Product Development Engineer will focus primarily on the development efforts of single use and reusable medical device disposables along with handling sustaining activities to support and improve existing products. The position will work closely with Manufacturing and Product Development teams to achieve quality, customer satisfaction, cost, safety, and business goals. You will be responsible for designing and maintaining medical device disposables for the isotope processing instrument (i.e., custom molded components and assemblies, custom machined components and assemblies, off-the-shelf components, reagents, tubing assemblies, packaging, vials, etc.).
The Product Development Engineer will resolve design, manufacturing, and sourcing issues. This includes individually fulfilling these essential functions and potential leadership of small teams including internal and external resources.
Responsibilitiesfor New Product Development Engineer:
- Provide engineering support to the project team to design and develop medical devices (disposable and reusable) from concept through market introduction.
- Supports complaint/CAPA/deviation/NCMR/out of specification investigations to determine the root cause of failures and resolve technical issues.
- Coordinate development activities to meet customer requirements.
- Support qualification activities for changes to manufacturing processes at supplier sites and introduction of equipment including tool validation, IQ/OQ/PQ.
Requirementsfor New Product Development Engineer:
- Bachelor’s degree in an Engineering discipline (Mechanical Engineering, Biomedical Engineering, Plastics Engineering, etc.)
- 1+ or more years of experience (prefer 2 or more) or equivalent combination of education and experience
- Familiarity with SolidWorks, FDA regulations, cGMP regulations, and pharmaceutical/medical device industry is preferred.