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Job Overview

Overview: We are looking for an experienced Contract R&D Engineer to contribute to the research and development of innovative medical devices. This role focuses on the use of metals in the medical device industry, specifically leveraging expertise in plasma welding, shape setting, and laser welding. The successful candidate will work closely with the internal engineering and manufacturing teams to ensure product design and process development are aligned with regulatory standards.

Key Responsibilities:

• Lead R&D efforts in developing metal components for medical devices using plasma welding, shape setting, and laser welding technologies.
• Research and innovate materials and methods that improve the functionality and safety of medical devices, especially in the area of biocompatible metals such as titanium, nitinol, and stainless steel.
• Collaborate on the design, prototyping, and testing of new products, ensuring they meet stringent FDA and ISO 13485 standards.
• Develop and optimize welding and shape-setting processes, ensuring they are scalable for manufacturing while maintaining quality and regulatory compliance.
• Conduct feasibility studies, failure analyses, and implement design improvements based on testing results.
• Work closely with manufacturing, quality assurance, and regulatory teams to ensure seamless integration of new designs into production.
• Prepare technical documentation, including test protocols, validation reports, and process development documentation.
• Provide ongoing technical support during the transition from R&D to production, ensuring all processes are robust and validated.

• Materials Science, Metallurgy, or related field.
• 10+ years of hands-on experience in plasma welding, shape setting, and laser welding in the medical device industry.
• Proven track record in medical device R&D, with an emphasis on metals and welding technologies.
• Strong understanding of FDA regulations, ISO 13485, and GMP requirements in medical device development.
• Experience in design validation, process development, and technical troubleshooting.
• Ability to work independently and deliver projects on time within a fast-paced, regulated environment.
• Excellent written and verbal communication skills, including the ability to prepare technical reports.

• Experience with cleanroom environments and sterilization processes.
• Knowledge of advanced material properties and their application in the medical device sector.
• Certification in welding technologies or relevant industry certifications.