R&D Engineer

Job Description Medical device R&D engineers should contribute to all stages of the product life cycle as needed to support our product portfolio, client's needs, and P&L objectives. This includes conceptualization, research, development, testing, commercialization, and post-launch support, which should comply with domestic and international regulations and local design control practices matters. Duties and Responsibilities Design medical devices following STEM design control procedures and all applicable regulatory guidelines. Conceptualize a new product idea or technology that can be applied to the design of new products. Analyze and evaluate design activities. Create and execute test programs. Collect necessary documents to transform the new product design into production. Evaluate product problems and defects based on customer or manufacturing complaints, formulate and implement design-related corrective action plans. Seek out and recommend improvements to existing products in terms of quality, cost, or functionality. Review, analyze and approve appropriate design deviations. Create and maintain product specifications. Maintain project and product documentation according to GMP, FDA, ISO, MDR, and other related regulations. Provide support for clients' product approval. Create documents included in risk management files. Communicate with internal and external manufacturers on product design, quality, and manufacturing-related issues. Complete special projects according to the requirements of the R&D manager. Qualifications Master's degree (M.S./M.A.) or Ph.D. in Engineering or other technical fields is required. An appropriate combination of education and experience is also acceptable. Proficient in 2D/3D CAD design software. Proficient in Microsoft Office. Ability to solve and analyze problems. Technical capabilities, including decision-making, communication (verbal and written), and effective internal and external reporting. Timely and effective responses to common inquiries. Work under general supervision with the expectation of a wide range of creativity and latitude. Locations Shirley, NY Job Type Full-time Job Family Research & Development Job ID

• 485341
• J-18808-Ljbffr STEMart Inc.