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Senior Manufacturing Engineer

Company: Ondine Research Laboratories
Location: Bothell
Posted on: November 11, 2018

Job Description:

The World Economic Forum has concluded in a recent report on global risks that "arguably the greatest risk...to human health comes in the form of antibiotic-resistant bacteria." Ondine Biomedical is the recognized global leader in Photodisinfection technology designed to prevent and treat complex, multi-drug resistant infections due to the growing global antibiotic resistance crisis. Photodisinfection, also known as antimicrobial photodynamic therapy, is a non-antibiotic technology that destroys a broad range of pathogens including virus, fungus and bacteria. We are looking for talented people that share our passion to join our team in our Bothell, Washington facility. Senior Manufacturing Engineer



The Senior Manufacturing Engineer will support our product realization efforts including: product development, sustaining engineering, supply chain management (including CM's and in-house manufacturing) and our quality management system while adhering to required regulatory standards.


Responsibilities include: Provide operational leadership for, and tactical execution of, corporate operations initiatives including manufacturing, sustaining engineering and order fulfillment. Author product manufacturing and quality plans. Prepare design verification and process validation plans and conduct verification and validation activities. Provide manufacturing and operations expertise to product development efforts including DFM, supply chain and logistics Lead design transfer activities to CM's or in-house manufacturing.
Contribute to and participate in the quality management system through corrective and preventing action, risk management, process development, quality system audits. Act as a program and project manager for operations, development, and corporate programs. As a member of supplier management teams, conduct supplier research, participate in supplier audit and selection, prepare supplier metrics and evaluations. Prepare research that would include among other things; technology and manufacturing trends, competitive situational analysis, cost reduction recommendations and product opportunities. Management of in-house manufacturing including oversight of resources.


Qualifications: Bachelor's degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering or other applicable engineering discipline 5-10 years relevant industry experience. Experience working within regulated environments including EN ISO 13485, 21 CFR820 and/or 21 CFR 210/211, MDSAP. Detail oriented, with effective planning, organization, and execution skills within a Collaborative and communicative style with ability to work within and to lead cross-functional teams and in a matrixed and entrepreneurial environment. Excellent verbal and written communication skills required, including adherence to formalized document control. Ability to adapt and respond to the needs of a growing organization conducting both R&D and commercialization activities. Familiarity with product design tools including SolidWorks CAD. Self-motivated and self-directed.




To apply please submit resume to: ondineops@ondinebio.com YourMembership. Keywords: Manufacturing Engineer, Location: Bothell, WA - 98011

Keywords: Ondine Research Laboratories, Seattle , Senior Manufacturing Engineer, Engineering , Bothell, Washington

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