Engineering Manager

Position Title: R&D Engineering Manager – Embedded Software 

 
A Day in the Life  

 
The R&D Embedded Software Engineering Manager in the field of dialysis technologies plays a pivotal role in shaping the future of life-saving medical devices. This position requires a keen understanding of the specialized software development processes in the medical device sector, with a strong emphasis on adherence to IEC 62304 and FDA guidelines. Leading with a vision for excellence in performance, quality and safety, you will guide the development of robust, reliable, and secure software solutions critical for advanced dialysis technologies.  This role works in close collaboration with other disciplines in Dialysis Technologies orbit, as Hardware Engineering, Mechanical Engineering, Single Use Devices, as well as other cross-functional teams like human factors, UI, quality, regulatory, PMO and medical affairs. In the end, the leader is responsible to further strengthen and continue our journey of world-class embedded software organization.  

Responsibilities:

• Lead the development and maintenance of embedded software for innovative dialysis devices, ensuring adherence to the highest standards of quality and safety. 
• Provide expert technical guidance and mentorship to the software development team, ensuring compliance with IEC 62304, FDA regulations, and other relevant medical device standards. 
• Foster collaborative and effective relationships with global software teams, ensuring a cohesive and aligned approach to software development. Leads and develops software discipline globally for Mozarc Medical 
• Champion state-of-the-art methodologies in software development, including Agile practices, DevOps, data analysis, and software test automation. 
• Ensure the implementation of safe and secure software design principles, aligning all development activities with the critical nature of medical device software. 
• Cultivate a high-performance software engineering team, focusing on skill development, coaching, and career progression. Manages internal and external design partners, suppliers and manufacturers as needed. 
• Ideate, evaluate and directs cross-discipline team towards preferred design options to meet product/performance requirements. Collaborates with IP Counsel as needed 

Must Have: 

• Bachelor’s degree in engineering  
• At least 5 years of relevant medical device software engineering experience  
• At least 10 years of relevant working experience in software/embedded environment 
• 10+ in medical device software engineering 

Nice to Have: 

• Comprehensive understanding on software development process, especially in regulated environment. 

• Familiarity with the latest software tools, solutions and automations used in the healthcare industry. Knowledge or familiarity of hardware and low level firmware 
• Exceptional leadership skills, capable of motivating and guiding teams within a global organization 
• Strong commitment to quality, safety, compliance, and ethical work practices 
• Proficiency with Agile Methodologies, DevOps practices, data analysis, and automated testing in software development environment 
• Excellent communication skills, ability to build relationships and foster teamwork across various functional groups and geographies. Proven ability to navigate complex project landscape, drive timely and effective delivery of software solutions. 
• Knowledge of different processor families and their operating environments