R&D Engineer Pharma​/Medical Device

Position: R&D Engineer Pharma / Medical Device
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.
Key Requirements   Min 4 years as R&D Engineer in a plant in Pharma or Medical Device
Degree in Engineering
Fluent English

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