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.

• 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.

• 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.

Shirley, NY

Full-time

Research & Development

#485341