MedTech Software System Engineer — Hybrid, SaMD

Coloplast; Denmark; Hybrid; DKK 700,000 - 900,000; Full time

Job summary

Coloplast is seeking a Software System Engineer to lead the rebuild of Heylo, the digital backbone of its ostomy leakage notification system. You will focus on needs elicitation, requirement creation, design control, and risk management within SaMD in a regulated medical device context.

You’ll bridge stakeholders, regulatory requirements, and technical teams, drafting traceable design specs while improving documentation automation and audit readiness.

Qualifications

• 3+ years experience in system engineering within SaMD or medical software.
• Experience authoring and reviewing software design documentation.
• Familiar with IEC/EN 62304 and ISO13485 design control.
• Experience in software verification and risk management processes.
• Knowledge of cybersecurity in medical software contexts.

Responsibilities

• Run workshops and analyses with Product Management to refine needs.
• Define and trace software requirements using Specification by Example and Gherkin.
• Lead software risk management and collaborate on cybersecurity with the Software Architect.
• Support documentation workflow improvements across the development process.

Skills

System engineering

Agile medtech

Regulatory understanding

Job description

Coloplast is seeking a Software System Engineer to lead the rebuild of Heylo, the digital backbone of its ostomy leakage notification system. You will focus on needs elicitation, requirement creation, design control, and risk management within SaMD in a regulated medical device context.

You’ll bridge stakeholders, regulatory requirements, and technical teams, drafting traceable design specs while improving documentation automation and audit readiness.