- Indianapolis, Indiana, United States
- Mid
- 2–5 years
Lead and execute complex technical projects within the medical device space, requiring strong ownership, autonomy, and the ability to manage multiple priorities with minimal supervision.
Responsibilities
- Stay current with ISO 13485, governmental regulations, medical device standards, and drug–device combination product requirements
- Support and prepare regulatory documentation to meet industry and compliance requirements
- Create and maintain documentation aligned with company policies and applicable regulations
- Analyze, plan, and execute project timelines and deliverables
- Develop and maintain detailed project schedules, ensuring accuracy and alignment with technical and business needs
Requirements
- Bachelor’s degree in Biomedical Engineering or a related field