Mike Luloh
Southlake
Summary
Dynamic software engineering leader with a proven track record at Alcon, driving innovation in safety-critical systems and regulatory compliance. Expert in fault-tolerant design and distributed team leadership, I successfully modernized development tools and enhanced R&D productivity, delivering cloud-based applications that meet stringent international standards. Passionate about fostering Agile practices and quality systems management.
Overview
33
33
years of professional experience
1
1
Certification
Work History
Director, Software Engineering
Alcon
01.2022 - 04.2025
- Scaled and led a distributed team of 17 engineers to improve R&D productivity by modernizing development tools, establishing SOPs, and embedding CI/CD, and shift-left testing practices across 8 global teams.
- Served as the SOP owner for software product development and AAMI SM/WG 01 voting member (IEC 62304 international standards committee), directing improvements that enhanced Alcon's compliance and development velocity.
- Delivered cloud-based, safety-critical applications with comprehensive traceability, automated V&V documentation, and fault-tolerant architectures meeting ISO 13485 and IEC 62304 requirements.
- Directed improvements to the internal Quality Management System and compliance practices, strengthening audit readiness, and aligning with international safety standards.
Associate Director, Surgical R&D
Alcon
01.2008 - 01.2022
- Led the development of the world's most popular commercial surgery planning digital health app at www.myalcon-toriccalc.com, where over 100,000 astigmatism-correcting surgeries per month are planned using Alcon ATIOLs.
- Spearheaded the development of a cloud-based surgical planning digital health app for a new class of ultra-premium IOLs, integrating AI, patient data, and inventory tools at www.myalcon-faiolcalc.com.
- Developed embedded control software for high-speed IOL production inspection systems, increasing throughput by 10x through real-time automation, robotics control, and fault detection algorithms.
- Built and mentored a nine-person software engineering team, instilling Agile practices and a strong compliance culture.
- Implemented a QMS for software development and V&V, aligned with ISO 13485 and IEC 62304, ensuring safety-critical compliance while enabling innovation.
Sr. Software Engineer II
Alcon
01.2001 - 01.2008
- Developed embedded real-time software for LASIK surgical instruments with sub-millisecond timing requirements, and safety interlocks.
- Implemented simulation tools and novel V&V processes for safety-critical embedded systems.
- Personal validation: I underwent photorefractive keratectomy using software I developed, achieving >20/15 vision results.
Lead Software Engineer
MTS Systems
01.1997 - 01.2001
- Designed embedded control algorithms and software for automotive engine testing systems used by Ford, GM, and other major manufacturers.
- Developed real-time data acquisition and control software with Ethernet-based communication for safety-critical automotive validation environments.
- Integrated comprehensive V&V processes into the product lifecycle, ensuring reliability and safety for automotive industry applications.
Software Engineer
CriTech Research
01.1994 - 01.1997
- Built embedded control software for FDA-regulated medical devices, including a stem cell incubator, an immunoassay analyzer, and a nuclear imaging system.
- Developed safety-critical control algorithms with fault detection and failsafe mechanisms.
Software Engineer
Ford Motor Company
01.1992 - 01.1994
- Contributed to automotive engineering tools, including 3D CAD exchange systems and NVH (Noise, Vibration, Harshness) testing simulations.
- Developed software for automotive validation and testing environments, ensuring safety and reliability standards.
Education
Bachelor of Science - Computer Science
University of Dortmund
GermanySkills
- Safety-critical system architecture
- Fault-tolerant design
- Distributed team leadership
- Regulatory compliance
- Quality systems management
- Agile implementation
- DevOps practices
- Full software lifecycle management
- Risk management strategies
- C programming
- C programming
- C# programming
- MATLAB expertise
- JavaScript development
- TypeScript proficiency
- QNX operating system
- Real-time Windows environments
- Bare-metal microcontroller programming
- Ethernet networking
- Serial and USB communication
- TCP/IP protocols
- CI/CD pipeline management
- Docker containerization
- Version control systems
- Automated testing methodologies
- Medical device software development
- Automotive systems engineering
- Industrial automation solutions
- Robotics engineering principles
- Digital health technologies
Certification
- Professional Scrum Master – Scrum.org
- SAFe Certified Practitioner
Languages
- English (Fluent)
- German (Fluent)
Citizenship
U.S. Citizen
Languages
English
Native/ Bilingual
German
Native/ Bilingual
Accomplishments
- Alcon's prestigous Innovation Award
· Method and System for Biometric Surgical Confirmation
o US20050109350 - Dec 16, 2003 (Pending)
o WO 2005/051195 A1 - June 9, 2005 (Issued)
· External device for controlling a laser during laser ablation surgery on the cornea and associated methods
o US20070149956 - Dec 13, 2006 (Pending)
o EP 1 803 426 A1 - July 4, 2007 (Issued)
References
References available upon request.
Timeline
Director, Software Engineering
Alcon
01.2022 - 04.2025
Associate Director, Surgical R&D
Alcon
01.2008 - 01.2022
Sr. Software Engineer II
Alcon
01.2001 - 01.2008
Lead Software Engineer
MTS Systems
01.1997 - 01.2001
Software Engineer
CriTech Research
01.1994 - 01.1997
Software Engineer
Ford Motor Company
01.1992 - 01.1994
Bachelor of Science - Computer Science
University of Dortmund