Overview

As a Clinical Product Manager (Medical Device Focus) at Oracle, you’ll provide clinical insight into product design, usability, and risk management for healthcare technologies. Collaborate across engineering, regulatory, and product teams to align development with ISO 14971, IEC 62366, and EU/US Clinical Evaluation standards. This IC4 role drives safer, user-centered medical device solutions.

Responsibilities

• Provide clinical expertise to guide product design, usability testing, and risk mitigation strategies.
• Collaborate with engineering teams to integrate human factors engineering per IEC 62366 standards.
• Lead risk management processes in compliance with ISO 14971 throughout the product lifecycle.
• Conduct clinical evaluations and usability studies to support regulatory submissions.
• Partner with regulatory affairs to ensure alignment with EU MDR, FDA, and global standards.
• Develop clinical use cases and validation protocols for medical device software features.
• Analyze post-market surveillance data to inform iterative product improvements.
• Advise product leadership on clinical trends and competitive usability benchmarks.

Qualifications

• Bachelor’s degree in Nursing, Biomedical Engineering, or related clinical field; advanced degree preferred.
• 5+ years in medical device product management, clinical affairs, or usability engineering.
• Deep knowledge of ISO 14971, IEC 62366, EU MDR, and FDA human factors guidelines.
• Experience with clinical evaluations and post-market clinical follow-up (PMCF).
• Strong cross-functional collaboration skills with engineering and regulatory teams.
• Excellent communication and stakeholder management abilities.

Benefits

• Comprehensive health, dental, and vision insurance coverage.
• 401(k) matching and employee stock purchase program.
• Flexible remote work options and generous PTO policy.
• Professional development stipend and tuition reimbursement.
• Wellness programs including gym memberships and mental health support.