Sr. Manufacturing Engineer - NPI Test
11911 North Creek Parkway South Bothell, Washington 98011 | Direct Hire
Position Description: Our Eastside client is looking for a Sr. Manufacturing Eng. to join their team for a full time role.
Provide support to the Instrument Manufacturing organization to facilitate efficient build and test operations and ensure production goals are met. This New Product Introduction (NPI) engineering position designs and creates medical device manufacturing processes, test systems, and instrumentation in a both development and sustaining environments.
Assist with design and manufacturing of new medical devices, providing Design for Manufacturability expertise. As a key contributor, drive continuous improvement efforts in the manufacturing and test processes to increase throughput, reduce cost, and improve quality, reliability, and yields while maintaining compliance with the medical device quality system.
- Provide line support for Instrument Manufacturing operations, including introduction of new products into manufacturing.
- Lead, manage, implement and execute multiple projects to support product development, manufacturing process and test development and continuous improvements, on time and on budget.
- Initiate, design, optimize, and develop test systems and instrumentation based on department and company objectives while complying with medical device industry requirements: IEC 60601-1, ISO 13485, 21 CFR/ GMP.
- Interface with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
- Provide technical expertise for investigation and closure of non-conformances, CAPAs and complaints.
- Document experiments, tests, and process development activities in technical reports. Perform validation activities including writing protocols and reports.
- Develop and design process monitoring systems to control and verify process requirements are achieved (SPC).
- Train production assemblers and technicians on new or modified equipment/processes.
- Evaluate, develop and manage outside OEM services.
- Contribute to determination of manufacturing engineering direction, with the involvement of peers and team members.
- Supervise Junior Manufacturing and Test Engineers and Technicians, including assigning duties and completing performance appraisals.
- Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with company values.
- Carry out other reasonable tasks as required by the Line Manager.
- Under supervision, Test System and Instrument Development, Timeline Planning, and Specifications with the involvement of team members and with design review
- Documentation of engineering conclusions in reviewed reports.
- Creation and approval of specifications, protocols, procedures, and change orders (DCOs).
- Preliminary selection of suppliers.
- Selection and purchase of equipment, materials and supplies with one-over review.
- Managing and driving projects from development to completion.
- Bachelor’ s degree in Electrical Engineering discipline plus 7 – 10 years of related experience in Product Development, Manufacturing and Test Engineering and New Product introduction.
- Expertise in medical device manufacturing following GMP, ISO 13485, IEC 60601-1, MDD, and QSR requirements.
- Expertise in PCBA and Box Build equipment and techniques.
- Knowledgeable in automated tests, and/or software validation on electronic devices or sub-systems such as (Black Box, White Box, Unit Test, Functional Test, PCBA Test, etc.)
- Diversified knowledge and experience in Process Qualification and Validation.
- Ideal candidate has skills in LabVIEW, C, Python and strong technical writing capability.
- Expertise in relevant materials fabrication equipment/techniques.
- Experience in broad range of DfX categories.
- CAD capability, SolidWorks preferred.
- Six-Sigma Green/Black belt a plus.
- Experience leading interdisciplinary teams and managing continuous improvement projects.
- HALT, DFM, Board bring-up, Final Test, Safety Test, Design Validation Experience, a plus.
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.