For our client, a leading company in the Pharmaceutical sector we are looking for a Hardware/Software Engineer
Background:
The Sub-Chapter Instrument Design Verification is part of R&D Near Patient Care, which is accountable for research and development activities on all systems of the Near Patient Care portfolio of our client.
We are looking for someone with a technical background, ideally in system engineering, software engineering or medical engineering who brings experience in software and hardware requirement engineering - and eventually testing - for diagnostic instruments.
The Perfect Candidate:
The perfect candidate brings over 5 years of experience driving the full product development lifecycle, with a sharp focus on requirements engineering within highly regulated environments, ideally in In Vitro Diagnostics (IVD) or medical device development. They possess a deep understanding of the V-model and extensive hands‑on expertise in requirement analysis, structuring, and breakdown using advanced ALM tools.
General Information:
* Planned Duration of Employment: 12 months
* Extension (for temporary contracts): possible
* Home Office: onsite presence preferred, home office to be discussed
Tasks & Responsibilities:
* Definition of technical requirements for diagnostic instruments based on business and customer inputs, risk ratings and context according to internal guidelines
* Knowledge in definition of requirements using EARS (Easy Approach to Requirements Syntax)
* Contribution to the development of requirement engineering concepts and strategies for software and hardware on different levels
* Review of requirements and specification
* Collaboration within the interdisciplinary development team
* Status reporting to respective project or product leader
Must Haves:
* 5+ years of experience working across full product development lifecycles with focus on
* Background in regulated environments, ideally within IVD or medical device development
* Strong requirements engineering experience, including ALM tools and requirement breakdown/structuring
* Certifications such as CPRE/IREB, CCBA/IIBA, or INCOSE are advantageous
* Experience with requirement analysis, test case creation, test execution, and defect lifecycle management
* Understanding of the V-model
* Strong analytical thinking, problem-solving, and ability to balance big‑picture and detail oriented work
* Experience moderating and collaborating with multidisciplinary stakeholders and teams
* Strong communication skills, autonomous working style, and pragmatic mindset
* Fluent English and German are required
#J-18808-Ljbffr