11911 North Creek Parkway South Bothell, WA 98011
Position Title: Manufacturing Engineer
Position Description: Our Bothell, WA client is looking for Manufacturing Engineer to join their Team.
- 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.
- 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.
- Exceptional Interpersonal and communication skills.
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.
I have worked in Technical staffing for over 17 years in the Pacific NW primarily, and Nationally. My specialty is finding candidates for contract, contract to hire and direct hire jobs in Technical & Engineering fields for some of the greatest Hardware & Software product development companies around. I listen to what you are looking for and will ensure your resume looks great. I am honest and communicative throughout the hiring process. I am passionate about putting our Veterans back to work, and helping underrepresented people get into STEM careers.