Sr. R&D Engineer
at HealthCare Recruiters International

Date Posted: 1/10/2019

Job Description

Sr. RD Engineer OVERVIEW OF POSITION Support the production of innovative medical devices in support of the companys strategic plan. DUTIES AND RESPONSIBILITIES Design and develop new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost. Solve complex problems at the product level. Conduct testing utilizing DOE methodology and other experimental design tools. Generate effective testing reports. Identify and initiate opportunities for improvement to device performance, quality systems, supply chain, or broader company objectives. Supervise assigned technicians and temporary workers. Lead and manage complex projects. Conduct complex design review meetings. Complete projects (including product enhancements) in an aggressive manner consistent with corporate objectives. Independently determine day to day tasks. Complete projects with exemplary documentation, leaving a legacy in design history files, specifications, etc. Maintain contact with and gather feedback from key physicians involved in the companys product development programs. Contribute to the intellectual property position of the company via invention and patent applications. Maintain accurate documentation of concepts, designs, drawings, and processes. Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to the companys products. Provide engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs. POSITION DESCRIPTION Procure and oversee outside vendors and consultants as required. Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions. Provide support in the resolution of product complaints and/or safety issues. Work with the Manufacturing, Clinical Affairs, Sales and Marketing, and Quality Assurance functions to coordinate pilot production of new products. Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations. Maintain a professional, credible image with key physicians, consultants, vendors, and co-workers. Work all required overtime. Perform other duties as assigned. MINIMUM EDUCATION REQUIREMENTS BSME or equivalent preferred. MINIMUM EXPERIENCE REQUIREMENTS With a BSME, 4 7 years of experience is required. With an MS, 3 6 years of experience is required. Catheter development experience strongly preferred. Experience in the medical device industry is also required. OTHER NECESSARY QUALIFICATIONS CAD proficiency. Working knowledge of the patent process. Ability to perform word processing and create basis spreadsheets. Ability to perform computerized project scheduling.

Job Snapshot

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