Mobile Engineering Manager — Regulated Medical Apps

ROM Utrecht Region; Utrecht; Hybrid; EUR 90,000 - 150,000; Full time

Job summary

ViCentra B.V. is seeking a Mobile Engineering Manager to own and evolve the Kaleido App and its mobile platform within a regulated medical device framework.

You will define foundations, processes, and quality standards while enabling innovation and scale. You will lead a mobile team (up to ~10) across Android and iOS, collaborate with security, systems, manufacturing, and regulatory teams, and manage external partners as we bring software in-house and strengthen Scrum practices in a compliant

Qualifications

• Proven leadership experience managing mobile engineering teams.
• Deep knowledge of medical device regulations and QMS including ISO 13485, IEC 62304, IEC 62366, FDA / 21 CFR 820.
• Strong understanding of mobile app development (Android and/or iOS) with hands-on Kotlin/Swift.
• Experience bringing externally developed software in-house.
• Lead the transition of a regulated app from external partner to internal ownership.
• Define and improve mobile software processes in a regulated environment.

Responsibilities

• Lead the transition of a medically regulated mobile app from an external development partner to internal ownership
• Define, implement, and continuously improve mobile software development processes within a regulated medical device environment
• Build and scale a mobile engineering team (growing to ~10 people) across Android, iOS, usability, and testing
• Establish and mature medical-device-compliant software development processes (ISO 13485, IEC 62304, IEC 62366)
• Own delivery of mobile software used in conjunction with medical hardware and cloud backends
• Drive collaboration across cyber security, systems, manufacturing, quality, and regulatory teams
• Act as the key technical and delivery interface with external partners and suppliers
• Introduce and strengthen Agile / Scrum ways of working within a regulated environment
• Proven leadership experience managing mobile engineering teams
• Deep knowledge of medical device regulations and QMS, including ISO 13485, IEC 62304, IEC 62366, FDA / 21 CFR 820
• Experience working with externally developed software and bringing it in-house
• Strong understanding of mobile app development (Android and/or iOS) and hands on background in Android (Kotlin) and/or iOS (Swift)
• Previous scale-up or rapid-growth environment experience

Skills

Medical device regs

Agile / Scrum

Mobile engineering leadership

Android Kotlin

iOS Swift

External partner mgmt

Regulatory QMS

Job description

ViCentra B.V. is seeking a Mobile Engineering Manager to own and evolve the Kaleido App and its mobile platform within a regulated medical device framework.

You will define foundations, processes, and quality standards while enabling innovation and scale. You will lead a mobile team (up to ~10) across Android and iOS, collaborate with security, systems, manufacturing, and regulatory teams, and manage external partners as we bring software in-house and strengthen Scrum practices in a compliant