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Senior Process Development Manager
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Process Development LeadThis position is responsible for leading the development and optimization of manufacturing processes for new drug delivery devices and combination products. Key objectives include pilot-scale manufacturing, process validation, collaboration with cross-functional teams, and coordination with external partners.Key Competencies:Proficiency in medical device regulations such as ISO13485, EU MDD/MDR & US FDA 21 CFR Parts 4 & 820, and industry standards like IEC60601, ISO14971, IEC62366, ANSI/AAMI HE75.Familiarity with process flow design, Design For Manufacture/Design for Assembly, automation, robotics, part handling, and process risk management.Possess a high level of integrity with a passion to work with dynamic teams in a rapidly growing organization.The ideal candidate will have experience in:Sustaining existing processes and continuously improving them through process enhancements and innovations.Collaborating with stakeholders across functions including R&D, Engineering, Operations, and Quality to ensure effective implementation of new technologies and processes.Developing and maintaining robust documentation to support regulatory compliance and auditing requirements.Leading and mentoring teams to deliver results-driven solutions and driving a culture of innovation within the organization.We offer a stimulating work environment with opportunities for professional growth and development. Our team is passionate about delivering high-quality solutions and making a meaningful impact in the field of medical devices.
