R&D Engineer Pharma / Medical Device Germany

Responsibilities

• Architects and executes the creation of medical device solutions by converting abstract clinical concepts into precise technical requirements and engineering blueprints.
• Curates specialized materials, manufacturing workflows, and external partners to fulfill design objectives, while auditing these designs against performance criteria, clinical environments, and international regulations.
• Directs the fabrication of experimental components for engineering assessments, pre-clinical research, and human clinical trials, while serving as a primary technical decision-maker.
• Engineers scalable production workflows by identifying critical process variables through statistical methodologies like DOE, encompassing the acquisition of new equipment, tooling design, and supplier negotiation.
• Authors comprehensive work instructions and standard operating procedures, generates detailed technical reports and material specifications, and manages the lifecycle of verification and validation protocols.
• Innovates proprietary engineering test methods and anatomically representative simulated-use models in partnership with lab staff, ensuring the rigorous validation of these assessment techniques.
• Conducts exhaustive bench testing and competitive analysis to evaluate development units and finalize all verification and validation requirements for new product systems.
• Educates technical teams on emerging design architectures and manufacturing processes, while leading cross-departmental training for operations and quality assurance groups.
• Manages the allocation of project-related capital and operational expenditures while performing and auditing detailed engineering cost-benefit analyses.
• Collaborates with Manufacturing, Quality, and Regulatory departments to ensure all organizational processes remain aligned with internal standards and global statutory guidelines.