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About the Job
The Director, Lab Systems Engineering is responsible for overseeing and managing all Software Engineering activities and functions related to Lab Operations. These activities include design and implementation of software systems to support lab activities, including material shipping and receiving, accessioning, pathology review, specimen preparation, sequencer interfacing, batch records, and lab device interoperations. In addition, the role leads the development of enterprise level systems to support vital business functions, including integration with off-the-shelf software systems. This position is also responsible for Quality Engineering and is fundamental in ensuring the high quality and integrity of the software systems which have 24X7X365 expected up-time. This role interacts with the Regulatory and Quality teams on a regular basis and adheres to SDLC procedures that support medical device standards. Finally, this role is responsible for the lab support operational team, and leads the day-to-day activities for Production support, engineering escalations, event and incident investigation, CAPA inquiries, and monthly support metrics.
• Lead the Lab Systems software engineering team to deliver enterprise scale software systems.
• Define and guide technical standards, architectures, and SLAs regarding performance and continuous hours of operation.
• Collaborate closely with the Lab Systems Product Owner to determine key objectives and deliverables required by the business.
• Oversee multiple software engineering teams developing interdependent software systems and provide key alignment and milestone coordination.
• Partner with other technology teams to develop, plan, implement and deliver systems that enable the business priorities for continued growth and expansion.
• Mentor the engineering team members and implement professional development plans for all members of the team.
• Support the SDLC procedures required for medical device software validation.
• Provide extended hours support as the primary coordinator for Production engineering escalations.
• Travel domestically up to 10% of the time.
• Other projects as periodically assigned.
• Bachelor's Degree in Computer Science, Software Engineering, or related field
• 10+ years of experience delivering mission critical commercial and/or enterprise scale software systems
• 10+ years of experience in the architecture, design and implementation of software systems solutions for infrastructure, applications, and compliance
• 5+ years of experience leading architects, senior and principal level engineers
• Master’s Degree in Computer Science, Information Security or related field
• 5+ years of experience leading geographically distributed engineering teams
• 5+ years of experience leading Quality Assurance teams
• 5+ years of experience leading Production Support teams
• Hands on experience with Cloud Architectures, Full Stack software development, and Single Page Application Frameworks, including AWS, Jenkins, Groovy, and Infrastructure as Code
• Technical expertise in the areas of application security architecture and Software development life cycles
• Experience with medical device validation, including 510K regulations and procedures
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI’s values: passion, patients, innovation and collaboration
Internal applicants, please use your FMI email address.
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