NPI Manufacturing Engineer
Location: Bothell, WA
Main Purpose of Job:
Assist with design and manufacture of new medical devices.
Main Job Duties & Responsibilities:
- Work with the R&D and manufacturing team to define requirements and design product and processes to launch catheter based medical devices.
- Create 3D Solid models and GD&T based production drawings of products.
- Interface with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
- Lead, manage, implement and execute multiple projects to support product development, manufacturing process development and improvement on time and on budget.
- Develop clear and well understood documentation which may include, but is not limited to, process and inspection procedures, protocols, deviations, drawings, and documentation.
- Write and execute process validation protocols (IQ, OQ, PQ) and associated reports.
- Provide necessary technical expertise associated with second tier supplier designs, manufacturing processes and supporting subsystems.
- Document experiments, tests, and process development activities.
- Train production trainers and assemblers on new or modified equipment/processes.
- Develop and manage outside OEM services
- Bachelor’s degree in Engineering discipline plus 7 – 10 years of related experience in Product Development, Manufacturing Engineering and Product introduction.
- Expertise medical device manufacturing following GMP, ISO 13485, MDD, and QSR requirements.
- Experience in New Product Introduction
- Diversified knowledge and experience in Process Qualification and Validation.
- Strong background in change and configuration management.
- Strong Technical writing abilities required.
- Expertise in relevant materials fabrication equipment/techniques.
- Experience in broad range of DfX categories
- CAD capability, SolidWorks preferred.
- Exceptional Interpersonal and communication skills.