Principal R&D Engineer, NPD for Cranial & Spinal Tech

Medtronic; Fort Worth (TX); On-site; USD 131,000 - 197,000; Full time

Job summary

Medtronic is a global healthcare technology leader seeking an experienced engineer to lead design and development of new products and QMS processes in a fast-paced environment. This role emphasizes cross-functional collaboration with Marketing, Regulatory, Quality, Manufacturing, and R&D to translate needs into clear requirements and robust, cost-effective solutions.

You will develop system architectures, perform analyses, test prototypes, and ensure compliance with ISO 13485 and FDA standards

Qualifications

• Bachelor’s degree in mechanical engineering or related STEM field.
• 7+ years technically related experience; or 5+ years with advanced degree.
• Experience with ISO 13485 and FDA regulated environments is preferred.

Responsibilities

• Lead cross-functional product development teams and drive engineering decisions.
• Develop system architectures, interfaces, and technical specifications.
• Collaborate with Marketing, Regulatory, Quality, Manufacturing, Service, and R&D.
• Translate stakeholder needs into measurable product and system requirements.
• Perform analyses and feasibility studies to optimize design performance and cost.
• Develop and maintain requirements traceability from needs to design outputs.
• Develop/test prototypes and troubleshoot hardware/software/firmware issues.
• Lead risk management activities including FMEA and risk controls.
• Ensure compliance with QMS procedures and regulatory submissions as needed.
• Mentor junior engineers and support environmental, health and safety rules.

Skills

Technical leadership

Cross-functional collaboration

System architecture

Regulatory awareness

Risk management

Education

Bachelor’s degree in mechanical engineering

Job description

Medtronic is a global healthcare technology leader seeking an experienced engineer to lead design and development of new products and QMS processes in a fast-paced environment. This role emphasizes cross-functional collaboration with Marketing, Regulatory, Quality, Manufacturing, and R&D to translate needs into clear requirements and robust, cost-effective solutions.

You will develop system architectures, perform analyses, test prototypes, and ensure compliance with ISO 13485 and FDA standards