Foresight Diagnostics is hiring a
Senior Director System Engineering

Summary

The job is for a Senior Director of System Engineering at Foresight Diagnostics, a molecular diagnostics company developing non-invasive cancer detection technologies. The role involves leading the design, development, and implementation of advanced diagnostic systems, ensuring compliance with regulatory requirements, and mentoring a team of engineers.

Requirements

• Bachelor’s or Master’s degree in Software Engineering, Biomedical Engineering, or a related field
• Minimum of 6 years of experience in system engineering within the molecular diagnostics, medical device or related industry
• Deep understanding of regulatory requirements, including CLIA, FDA, ISO 13485, 21 CFR Part 820, and IEC 62304

Responsibilities

• Lead and mentor a team of engineers, fostering a collaborative and innovative work environment
• Develop and execute the system engineering strategy aligned with the company’s goals and regulatory requirements
• Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Clinical to ensure cohesive product development and operations
• Oversee the design, development, and validation of diagnostic systems, ensuring integration of software components and the flow of data
• Ensure systems meet performance, reliability, and scalability requirements
• Lead the architecture and design of system interfaces, data management, and analytical tools
• Ensure all software components comply with relevant regulatory standards such as FDA’s 21 CFR Part 820 (Quality System Regulation) and IEC 62304 (Medical Device Software Lifecycle Processes)
• Lead software validation and verification processes, ensuring documentation and testing meet regulatory requirements

Preferred Qualifications

• Knowledge of bioinformatics and data analysis tools, a strong plus
• Knowledge and experience medical device cybersecurity, a strong plus

Benefits

• The role offers a salary between $225,000-265,000
• Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match