Development Engineer / Product Development Engineer – Single-Use Systems

Project overview

Development Engineer / Product Development Engineer – Single-Use Systems

For a demanding development project in the biopharmaceutical environment, we are looking for an experienced development engineer with a technical background in product development, plastics technology, or fluid technology.

The focus of the project is the further development of existing designs for a small-scale single-use flow kit and the transfer of the underlying concept to two further scalable single-use systems in the biopharmaceutical upstream and downstream environment.

The focus is on the development and specification of plastic fluid lines, tubing systems, and other single-use components such as filters, pumps, and sensors.

The goal is to create a validation-capable and production-ready design as the basis for prototype construction and subsequent industrialization.

Responsibilities

Your Qualifications

• Evaluation, further development, and technical elaboration of existing designs for single-use assemblies in the biopharmaceutical environment
• Definition and specification of plastic fluid lines, tubing systems, and relevant single-use components
• Technical evaluation and selection of suitable components, considering functional, qualitative, and regulatory requirements
• Conducting and supporting design reviews and documenting technical decisions
• Creation and maintenance of product specifications, bills of materials, and development documentation
• Maintenance and creation of associated SAP documentation
• Documentation of technical evaluations, design decisions, change requests, as well as quality and production-relevant requirements
• Development and documentation of verification and validation concepts
• Evaluation, analysis, and documentation of test results
• Coordination of the development solution with the relevant specialist departments
• Provision of a coordinated and documented development solution for prototype construction and subsequent industrialization

Requirements

• Completed technical degree or comparable qualification, e.g., in mechanical engineering, plastics technology, process engineering, biotechnology, or a related field
• Sound experience in technical product development or design
• Knowledge of plastics technology and/or fluid technology
• Experience with technical specifications, bills of materials, and development documentation
• Understanding of design concepts, system architectures, and technical solution options
• Experience with design reviews and technical decision-making processes
• Knowledge in the evaluation and specification of technical components and assemblies
• Understanding of quality-relevant and regulated development processes
• Good German and English language skills

Nice to have

Tools Used

• Experience with single-use systems or single-use assemblies
• Knowledge in the biopharmaceutical upstream and downstream process environment
• Experience with tubing systems, plastic components, filters, pumps, and sensors
• Industry knowledge from pharma, biotechnology, or medical technology
• Experience with verification and validation processes
• Knowledge of SAP and Polarion
• SAP
• Polarion

Project details

Göttingen

Immediately

12 months with extension option

Approx. 20 person-days per month

Remote Share: Approx. 50%

Project Languages: German and English

Industry: Pharma / Biotechnology / Medical Technology

• Start: ab sofort
• Duration: 12 Monate
• Remote: hybrid
• Location: Göttingen, Deutschland, DE
• Languages: German