Design Control & Development Process Manager (IVD) - RZ

• Start Date: 16 February 2026

• Latest Possible Start Date: 16 March 2026

• Planned Duration: 12 months

• Extension: Very likely (approved budget)

• Location: Rotkreuz

• Workload: 100%

• Home Office: Yes, less than 50%

• Team Size: 28 people

• Department: Design Control Excellence CH (DSRSPC)

The Design Control Excellence CH organization is looking for a motivated Process Manager with a solid understanding of IVD product development. In this role, you will actively support development teams by providing process guidance, continuously improving development processes and ensuring high-quality documentation across multiple projects.
You will work in a highly regulated environment and contribute to the consistent and compliant execution of development activities.

The successful candidate holds a university degree in Life Sciences, Natural Sciences or Engineering and has gained initial hands-on experience in product development, either through professional roles or internships.
A strong technical understanding of development and design control processes is essential. Experience with databases and process management methodologies is an advantage. Previous exposure to the diagnostics industry or GMP-regulated environments is highly valued.

• Provide process guidance, optimization and documentation support for development projects (systems and assays)

• Apply and support processes related to Requirements Management, Risk Management, Configuration Management, Verification & Validation, Defect Management and Usability Engineering

• Support the translation of multi-level requirements using structured requirements management processes

• Perform detailed risk assessments based on documentation, statistical analyses, reports and market trends in collaboration with cross-functional stakeholders

• Ensure risks and requirements are consistently maintained in databases and aligned across multiple projects

• Deliver timely, accurate and high-quality risk and requirements documentation

• Establish and execute Configuration Management activities within complex development programs

• Support development projects in the role of Verification Manager, including planning, guidance, training and reporting

• Manage project-related interfaces with Development, Global Platform Support, Design Quality Assurance, Regulatory Affairs, Medical Affairs, external suppliers and other internal functions

• Collect, consolidate and structure information from relevant stakeholders

• Independently execute assigned work packages within the defined scope

• Organize and manage own workload effectively to meet project timelines and quality standards

• University degree in Life Sciences, Natural Sciences or Engineering

• Strong technical understanding of development and design control processes

• Excellent written and verbal communication skills in English; German is an advantage

• Experience with databases is preferred

• Experience in process management (Risk, Requirements, Configuration and/or Verification Management) or product development activities such as testing is a plus

• Initial experience in product development within a highly regulated environment is preferred

• Experience in the diagnostics industry and GMP-regulated environments is an advantage

• Strong analytical skills, structured and reliable working style, ability to prioritize and manage multiple tasks effectively

• Ability to lead through influence, drive decisions, handle conflicts and adapt to changing project environments

• Strong communication and presentation skills

• Open-minded, detail-oriented team player