Principal Mechanical Engineer

Mechanical Engineer Waltham, Massachusetts General Summary The Principle Mechanical Engineer role manages all aspects and phases of medical device development as part of a highly collaborative team in a fast-paced environment. Proven experience in bringing complex mechanical and electromechanical medical devices through all stages of product development, regulatory milestones and into production. This role reports to the Manager, Mechanical Engineering. Essential Job Functions Leadership: Leads, plans, organizes, and manages projects of significant scope. Assist and mentor staff engineers. Engineering Design and Technology Development: Investigates and evaluates existing technologies. Designs and implements new methodologies, materials, machines, processes, or products to bring concept to market, including essential product and process documentation. Design Development: Develops new designs from initial concept to market release using appropriate CAD and analytical tools and through investigation of available products, processes, and materials. Communication: Communicates with clients as well as internal team members, contractors, and suppliers, maintaining good relations and a clear, common understanding of project status, responsibilities, and issues. Documentation: Creates and maintains detailed documentation throughout all phases of research and development. Quality Management: Creates plans, procedures, protocols, and contributes to the generation of risk analyses. Conducts product verification and contributes to components of DHFs and DMRs for products under development. Customer Focus: Provides professional, reliable, and prompt service to internal and external customers. Works in partnership with others to meet and exceed customer expectations, interprets customers' needs and takes appropriate action, and follows through on customer inquiries in a professional and timely manner. Travel: Occasional overnight travel may be required to service client meetings, supplier meetings, and cross-office work. Other duties as assigned. Required Education, Experience and Specialized Knowledge and Skills Bachelor’s degree in Mechanical Engineering. Minimum of 12+ years of medical device project design and development experience. Proficient with Solidworks modeling and analysis software. Experience with FDA QSR and ISO 13485 medical device regulations. Experience with Risk Analysis tools consistent with ISO 14971. Familiarity with EN 60601, Safety requirements for medical electrical systems. Familiarity with US FDA regulations, i.e. 501(k), IDE, PMA. Expertise in mechanical and electromechanical medical devices (Class I, II and III). Expertise in all phases of product development from concept design through transfer into manufacturing. Experience building and maintaining supply chains and transferring products into manufacturing. Experience working in a fast-moving, small company environment between two locations. Willingness and ability to get hands‑on with mechanical engineering tasks. Location Archimedic - MA Job Type Full-Time Pay Rate $100,000 - $130,000 Equal Opportunity Employment Statement View email address on click.appcast.io Archimedic is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, or disability. Archimedic is committed to ensuring that a disabled employee has reasonable accommodations to successfully perform their role, while considering potential impacts to ongoing operations. Team members in Archimedic's Pennsylvania location must be able to use the stairs to move between office floors (No elevator available). Archimedic is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Application Status This position is currently accepting applications. #J-18808-Ljbffr