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Development Engineer Medical device

Company: Affinity Executive Search
Location: Framingham
Posted on: November 14, 2018

Job Description:

Our client is an early stage medical device company developing an innovative, elegant, and superior approach to the rapid cessation of bleeding. If you are looking for a challenge and want to help a business grow, this is the opportunity for you. They need a Development Engineer that will lead biomaterial(s) based device development efforts. As a hands-on technical leader, you will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, preclinical studies etc. Extensive collaboration with internal and external partners. RESPONSIBILITIES: * Provide project and technical leadership on cross-functional team for devices through preclinical development, product registration and commercialization. * Lead all project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation. Responsible for clear, concise, well written design history documentation, EU technical files, and manufacturing specifications. * Establish maintain detailed project plans define risk and recommend contingency plans * Lead the creation of design control elements to comply with medical device regulations to support the development of products in accordance Product Development Process and Design Control requirements as well as compliance with Good Manufacturing Practices (Quality Systems Regulations), Standard Operating Procedures, and Safety requirements. * Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. REQUIREMENTS: * BS degree in Engineering required Masters degree preferred. * 5 + years medical device experience coupled with development and commercialization success * Strong hands on experience in injectable biomaterials based device design/development ideal * Technical leadership experience with biomaterials delivery system development and scale-up * Leading projects with external design, development and manufacturing partners * Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820) and ISO13485 requirements, DFSS certification is desirable. * Strong communication skills (written and verbal), including experience presenting in front of cross-functional audiences * Must be able to multitask, handling a variety of projects simultaneously

Keywords: Affinity Executive Search, Boston , Development Engineer Medical device, Healthcare , Framingham, Massachusetts

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