Job description
[Applicants: Be among the first 25 applicants | Industry: Medical Equipment Manufacturing and Hospitals and Health Care | Type: Full-time | Level: Not Applicable]
Job Function SummaryThe Manager, Systems and Software Engineering will lead a multidisciplinary team of software and electrical engineers in the design, development, and maintenance of active implantable medical devices (AIMDs).Reporting to the Director, Product Development, Implantables, this role is accountable for ensuring that designs meet clinical performance targets, safety requirements, and international regulatory standards, while driving innovation and technical excellence.Major Areas of AccountabilityLeadership & ManagementLead, mentor, and develop a cross-functional engineering team covering embedded software, firmware, and associated systems.Allocate resources, set priorities, and manage workload to meet project timelines and deliverables.Foster a culture of innovation, technical rigor, and quality compliance.Strong people management skills with the ability to inspire, coach, and develop talent.Excellent cross-functional collaboration and communication abilities.Strategic thinking with hands-on problem-solving skills.Technical OversightGuide the architecture, design, and integration of embedded software for AIMDs.Ensure adherence to applicable standards such as IEC 60601, ISO 14708, ISO 14971, IEC 62304, and related AIMD requirements.Collaborate with all functions within R&D, and across the organization, inlcuding clinical experts to ensure holistic product performance.Project & Process ManagementSupport product lifecycle management from concept through verification, validation, transfer to manufacturing, and post-market support.Ensure rigorous risk management practices, including hazard analysis and FMEA, are applied to all designs.Champion design control processes in accordance with FDA 21 CFR Part 820 and EU MDR requirements.Coordinate with Quality, Regulatory, and Clinical teams to ensure regulatory submissions are supported with robust technical documentation.Innovation & Continuous ImprovementDrive adoption of best practices in model-based design, design for manufacturability, and design for reliability.Evaluate and integrate emerging technologies to enhance device capabilities and patient outcomes.Identify opportunities to streamline development while maintaining complianceColoplast employees are required to conduct business to the highest ethical and professional standards...
