Medical Device Clinical Product Owner - Cardio/Pulmonary

Medical Device Clinical Product Owner

This role requires a visionary and accomplished Medical Device Clinical Product Owner to lead new product development in the cardio/pulmonary area. The ideal candidate combines deep clinical expertise, strong leadership, and business acumen to drive innovation.

Responsibilities:

- Strategy and research: Define clinical use cases and product requirements by liaising with medical practitioners, OEM partners, and engineering teams. Conduct market and competitive analysis to shape product strategy.

- Product development: Guide the iterative design and development process by translating clinical requirements into features and product specifications for hardware, software, and biosensors.

- Regulatory and quality assurance: Manage product approvals by demonstrating a solid understanding of FDA regulations (510k, PMA) and ISO 13485. Oversee the creation of Clinical Evaluation Reports (CERs) and manage risk, including the mitigation of potential device hazards.

- Clinical trials: Assist in managing clinical trials to prove a device's safety and efficacy.

- Manufacturing and supply chain: Support manufacturing by advising on supplier selection and ensuring compliance with good manufacturing practices (GMP).

Required qualifications:

- Education: Advanced medicine (MBBS) or biomedical degree, with a specialization in cardio/pulmonary preferred.

- Experience: 10+ years in medical device development, including ECG/EEG and similar devices.

- Skills: Strong research, problem-solving, critical thinking, and communication skills are essential