Hardware/Software Engineer – Diagnostic Instruments

About the role

We are seeking a Hardware/Software Engineer to join the Sub‑Chapter Instrument Design Verification team within R&D Near Patient Care. The role focuses on defining and managing requirements for diagnostic instruments in a highly regulated IVD environment.

Key responsibilities

• Define technical requirements for diagnostic instruments based on business inputs, risk assessments and internal guidelines.
• Apply the EARS (Easy Approach to Requirements Syntax) method for clear requirement specification.
• Develop and refine requirement‑engineering concepts and strategies for both hardware and software components.
• Review and validate requirements and specifications in collaboration with an interdisciplinary development team.
• Report status to project or product leaders and support multidisciplinary stakeholder coordination.

Required profile

• Minimum 5 years of experience across the full product development lifecycle with a focus on requirements engineering.
• Background in regulated environments, preferably IVD or medical device development.
• Strong understanding of the V‑model and experience with requirement breakdown and structuring.
• Proven ability to work autonomously, communicate effectively in English and German, and balance big‑picture and detail‑oriented tasks.

Required skills

• Requirement engineering
• ALM tools
• EARS (Easy Approach to Requirements Syntax)
• V‑model methodology
• Test case creation and execution
• Defect lifecycle management

What we offer

• 12‑month fixed‑term contract with possible extension.
• Location in Rotkreuz, Switzerland with 20‑30 % travel.
• Hybrid work mode – onsite presence preferred with occasional home‑office.
• Opportunity to work in a multidisciplinary team of about eight members on a project of roughly 80 participants.