1970-01-01Davis Companieshttp://daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svgfull-time325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]

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Development Engineer

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    Development Engineer
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We are currently partnering with a Medical Device manufacturing company located in near Boston, MA looking to add an R&D Engineer to their growing team.  This is a long-term contract position.

•    Contributes to all aspects of product development activities and product Design History Files, such as; requirements creation/documentation, ideation/prototyping, design/development documentation, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions. 
•    Develops engineering solutions and innovations 
•    Supports or leads efforts to evaluate and identify design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements. 
•    Develops verification and validation testing strategies, authors testing protocols and reports, and ensures products meet and/or exceed established specifications. 
•    Maintains an understanding of applicable industry guidance documents and testing standards and ensures appropriate consideration and compliance. 
•    Employs statistical techniques to establish exceptional product quality, reliability, and robustness. 
•    Supports in ensuring product and performance specifications are appropriate and accurate. 
•    Supports and/or directs internal and external design partners, suppliers and manufacturers as needed.
•    Leads and/or supports testing to support marketing collateral, training programs, and launch activities.
•    Provides regular updates to engineering and marketing leadership on product status and advancement. 

•    Bachelor’s degree in Engineering Experience
•    Minimum year of related experience: 5+ years or 4+ years with MS or 0-2 years with PhD. Skills/Competencies/Other considerations: 
•    Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process. Experience in handheld electro-mechanical devices is preferred.
•    Working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.). 
•    Capable of leading & developing many of the Design Control deliverables required to document a product design and establish compliance with Design Inputs with appropriate specificity and quality. 
•    Solidworks experience
•    Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
•    Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab). 


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