Company Description

Focalyx is a private MedTech software and medical device company headquartered in Miami, FL. We specialize in the diagnosis and treatment of prostate cancer. Our Focalyx Fusion software supports computer-assisted surgical planning and provides real-time operative guidance for minimal invasive prostate procedures.

We bring an all-in-one solution into the medical office setting, offering AI-driven diagnostic and therapeutic targeted interventions.

Experience: 2 or more years of professional experience with a focus on software as a medical device (SaMD).

Responsibilities:

• Reviewing the current state of the system and adapting it to prepare for compliance with the EU Medical Device Regulation (MDR)
• Maintaining the Quality Management System (QMS) in compliance with ISO 13485 standards, which requires:
• Conducting and/or supervising yearly quality activities, including supplier assessments, post-market surveillance, internal training, performance reviews, management reviews.
• Leading internal and external audits, and handling and documenting software anomalies, non-conformities and corrective actions.
• Leading cybersecurity activities, in compliance with the latest FDA guidelines.
• Handling Design Change Requests, Design Controls and maintaining all Technical Documentation for the device already placed on the market
• Reviewing records from technicians in the field: customer complaints, customer orders, manufacturing and inspection reports, installation and servicing reports, etc.
• Participation on trade shows, conducting or assisting in demonstrations on the use of the SaMD solutions.
• Providing or assisting on technical support, device registrations

Requirements:

• Bachelor’s or master’s degree in biomedical engineering or related field.
• Over 2 years of professional experience working with QA/RA.
• Understanding of ISO 13485, ISO 14971 and IEC 62304 standards for QMS compliance.
• Assertive communication skills: conducting management reviews, and providing team training.
• Ability to adapt to changing regulatory requirements, particularly familiarity with MDR.

Additional Preferred Qualifications:

• Certification in Quality Management Systems (e.g., Certified Quality Engineer).
• Experience working in cross-functional teams within a regulated industry.
• Software coding in C or Python.
• Azure.

Application Process:

Interested candidates should submit their resume along with a cover letter outlining their relevant experience and qualifications to apluchino@focalyx.com