Key Responsibilities

• Translate business vision into actionable development requirements (Agile team collaboration)
• Develop and manage Software Design History File (DHF)
• Support project documentation/materials via SAP
• Maintain JAMA tool and generate required DHF documentation

Job Qualifications

• 1+ year experience in medical device industry (Class III/cardiovascular preferred)
• Knowledge of FDA/ISO requirements and quality policies
• Limited travel required

Preferred Qualifications

• Experience with FDA-regulated products
• PMP Certification
• Agile development with Continuous Discovery/Delivery mindset
• SaaS delivery experience
• Direct collaboration with software engineers