managing quick turn medical device OEM projects
responding to Requests for Quotes
prototyping catheters and balloon sub-assemblies
hands-on catheter/balloon design, development, and assembly experience
accurately predict project costs, material lead times, and delivery schedules during quoting process
develop bills of materials and assembly method, provide training to technicians and assemblers
work with areas including: complex catheters, steerables, smart catheters, balloons
develop balloons and catheter subassemblies according to customer design, performance, and quality specifications
develop products and processes that are reliable as well as identify risks to the project, develop contingency plans
review and prepare status reports, modify schedules, and project plans as required
keep stakeholders, customers, and others informed of project status and/or related issues
provide technical leadership, root cause analysis, and resolve customer or project related problems
apply design controls from initial customer requests throughout the products life cycle
involved in developing technical documentation: protocols, including verification and validation testing, drawings, calculation and/or FMEA
collaborate to develop quality assurance, testing, regulatory compliance, and quality plans
address customer's issues: improve performance, appearance, and impact on end-user

Requirements

Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering required
Master's degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
Proven balloon development experience
5 years' or more experience in Medical Device development or manufacturing
Working knowledge of manufacturing processes related to medical device manufacturing
Ability to prioritize and work independently as a self-starter with strong proactive work ethics
Experience with design controls, FDA regulation, GMP practices, and QSR requirements
Proficient in Microsoft Office, Project, Minitab, and Solidworks preferred
Experience with Risk Analyst tools and procedures
Proven track record in Leadership role and utilizing Project Management
Proven track record in product development, design, and working closely with manufacturing
Demonstrated customer relations, problem solving, and product development skills
Ability to influence across boundaries, drive collaboration, and develop product to meet expectations
Must be well-organized, detail-oriented, with excellent oral and written communication skills

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

balloon developmentcatheter designproject managementdesign controlsrisk analysisverification and validation testingFMEAmanufacturing processesquality assuranceregulatory compliance

Soft Skills

leadershipproblem solvingcustomer relationscollaborationorganizational skillsdetail-orientedcommunication skillsself-starterproactive work ethicsability to prioritize

Certifications

Bachelor's degree in EngineeringMaster's degree in Engineering