**Who this is for** This position is for an experienced engineering leader tasked with managing software development teams in the regulated, high-acuity medical
Work type: unknown
Location: Kuopio
Type: Full-time
**Who this is for** This position is for an experienced engineering leader tasked with managing software development teams in the regulated, high-acuity medical device industry. **Key highlights** You will bridge the gap between technical excellence and regulatory compliance, overseeing the full software lifecycle from design through to audit-ready documentation in an environment that prioritizes patient safety and continuous improvement. **You might be a good fit if you...** - Have significant experience leading software teams and delivering safety-critical products under standards like IEC 62304. - Are comfortable navigating regulatory audits and maintaining compliance within Agile or V-model frameworks. - Possess strong coaching and mentorship abilities to foster a culture of quality, psychological safety, and innovation. - Demonstrate excellent communication skills, capable of influencing strategy across product, clinical, and quality functions.
# Job Description Summary
The Senior Manager, Software Engineering will lead the team responsible for the design, development, verification, and maintenance of software used in a high acuity care environment. This role combines technical leadership, people management, and operational excellence, ensuring delivery of high-quality, safe, and compliant software aligned with business objectives and regulatory requirements. The successful candidate will work closely with cross‑functional partners including Product Management, Systems Engineering, Quality, Regulatory Affairs, Clinical, and Operations to deliver software that meets customer needs while complying with global medical device regulations.
# Job Description
Senior Manager – Software EngineeringPrimary site: Kuopio, Finland (GE HealthCare)
Work model: Hybrid
Office presence required: 3 days per week on site
Home office: 2 days per week
Remote work:Not allowedRole Summary
The Senior Manager, Software Engineering will lead the team responsible for the design, development, verification, and maintenance of software used in a high acuity care environment. This role combines technical leadership, people management, and operational excellence, ensuring delivery of high-quality, safe, and compliant software aligned with business objectives and regulatory requirements.
The successful candidate will work closely with cross‑functional partners including Product Management, Systems Engineering, Quality, Regulatory Affairs, Clinical, and Operations to deliver software that meets customer needs while complying with global medical device regulations.
Roles and ResponsibilitiesTechnical & Delivery Leadership: Own software development execution within own team's area of responsibility. Support adoption of modern software engineering best practices (e.g., CI/CD, DevOps, test automation) within the constraints of regulated development.
People & Organizational Leadership: Lead a high‑performing software engineering team. Promote psychological safety, diversity, and inclusion within the team. Provide coaching, mentoring, and performance management; foster a culture of accountability, quality, and continuous improvement. Partner with HR and leadership on hiring, workforce planning, and succession planning.
Regulatory & Quality Compliance: Ensure compliance with applicable medical device software regulations and standards (e.g., IEC 62304, ISO 13485, MDR). Partner with Quality and Regulatory teams to support audits, inspections, and submissions. Ensure software lifecycle documentation (requirements, design, verification, validation, risk management) is complete, accurate, and audit‑ready. Champion a “quality by design” mindset across software teams.
Cross‑Functional Collaboration: Work with Program Management to define scope, milestones, risks, and dependencies. Communicate progress, risks, and trade‑offs clearly to senior leadership and stakeholders. Support post‑market activities, including incident investigation, root cause analysis, and corrective actions.
Required Qualifications