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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