Overview:

The Product and Program Manager will lead the development and lifecycle management of our implanted cardiac devices. This role requires a combination of technical expertise, clinical understanding, and strategic leadership. The successful candidate will ensure products meet the highest quality, safety, and regulatory standards.

Responsibilities:

• Oversee all stages of product development, from concept to post-market surveillance.
• Coordinate and lead cross-functional teams including engineering, clinical, regulatory, quality, and business development.
• Drive technical development, including system design, integration, and validation.
• Collaborate with clinicians to define product requirements and conduct clinical trials.
• Ensure compliance with regulatory standards (e.g., FDA, ISO).
• Develop and execute comprehensive project plans and timelines.

Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
• Minimum 8 years of experience in medical device product development and management, with a focus on implanted cardiac devices.
• Proven track record in product ownership, technical development, and clinical validation.
• Strong understanding of clinical needs and ability to translate into technical requirements.
• Experience leading clinical trials and collaborating with clinical teams.
• Demonstrated expertise in FDA regulatory submissions and compliance.
• Exceptional leadership, project management, and communication skills.
• Strong problem-solving and analytical abilities.

Preferred Qualifications:

• Advanced degree in a relevant field.