SENIOR R&D ENGINEER (34131)

Job Summary

The Senior R&D Engineer is responsible for developing new products from concept to commercialization. This includes research, planning, idea creation and realization, concept development, specification generation, maintenance of existing product designs, testing for verification and validations, and effective communication with team members, management, and customers.

Essential Functions, Duties, And Responsibilities

• Lead and actively participate in the design and development of new medical devices, ensuring that they meet the highest standards of quality, safety, and efficacy.
• Perform research and testing on product concepts, new, and existing products.
• Conduct material, design and process changes to existing products by following design control processes and analyses of defects.
• Identify areas to streamline or improve cycle time and quality.
• Stay up-to-date with the latest FDA regulations, guidance documents, and industry standards related to medical devices.
• Apply this knowledge to develop and maintain compliant design control processes and documentation.
• Collaborate with regulatory affairs teams to create and execute regulatory strategies for new product submissions, including 510(k) premarket notifications, PMA (Pre-market Approval) applications, and other regulatory submissions.
• Establish and manage design control procedures, including risk management, design verification and validation, design transfer, and change control processes in alignment with FDA requirements and ISO standards.
• Identify, assess, and mitigate risks associated with product development, ensuring that risk management processes comply with FDA expectations and international standards (ISO 14971).
• Work closely with cross-functional teams, including quality assurance, manufacturing, and clinical affairs, to ensure seamless product development and regulatory compliance.
• Oversee and conduct testing for verification and validation activities to demonstrate product safety, performance, and effectiveness, in accordance with FDA regulations.
• Prepare and maintain detailed documentation of all R&D activities, including design history files, technical files, and regulatory submissions. Ensure timely and accurate reporting to regulatory authorities.
• Address technical challenges and issues that arise during product development, providing innovative solutions while maintaining compliance.
• Drive continuous improvement initiatives in R&D processes and practices to enhance efficiency and effectiveness while maintaining compliance with FDA requirements.
• Provide guidance and mentorship to junior engineers and team members on FDA regulations and best practices for medical device development.

Qualifications

• BS in Engineering (Mechanical, Bioengineering, Biomedical) or comparable technical/medical field required.
• Master’s degree in engineering (Mechanical, Bioengineering, Biomedical) or comparable technical/medical field strongly preferred.
• Thorough understanding of FDA regulations, including 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 807 (Establishment Registration and Device Listing).
• Experience with ISO 13485 and ISO 14971 standards is highly desirable.
• Profound understanding of mechanical testing and product development processes.
• Strong problem-solving skills and the ability to work effectively in cross-functional teams.
• 5-7 years engineering experience in design and development, medical device preferred.
• Prior experience with 3D CAD modeling software such as Solidworks, Freeform.
• GD&T experience applied to engineering drawing.
• Proficient user of Microsoft Office applications.
• Prior Windchill experience would be a plus.