Job Description

Job Summary

The Senior R&D Engineer is responsible for developing new medical device 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, as well as effective communication with team members, management, and customers. The R&D engineer will be expected to provide additional leadership and technical mentoring.

Responsibilities

• Product Development- Lead and actively participate in the design and development of new medical devices
• FDA Compliance- stay up-to-date with the latest FDA regulations, guidance documents, and industry standards related to medical devices.
• Regulatory Strategy: 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.
• Design Control - 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.
• Risk Management -identify, assess, and mitigate risks associated with product development, ensuring that risk management processes comply with FDA expectations and international standards (ISO 14971).
• Training and Mentorship -provide guidance and mentorship to junior engineers and team members on FDA regulations and best practices for medical device development.

Educational And Experience Requirements

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

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