11911 North Creek Parkway South Bothell, WA 98011 | Contract
Position Title: Manufacturing Engineer
Position Description: Our East side client has an exciting opportunity for a Manufacturing Engineer with NPI, Solidworks and Medical Device experience.
- Work with the R&D and manufacturing team to define requirements and design product and processes to launch 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.
- Supervise Junior Manufacturing Engineers and Technicians, including assigning duties and perform training and mentoring.
- 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.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.
Benefits Package: Protingent offers competitive salary, 100% paid health insurance, education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.