• Apply the Risk Management program per ISO14971 with applied statistical techniques.• Responsible for the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive continuous improvement. • Participate in the Process Performance Qualification (PPQ) conformance lot manufacturing that includes increased testing to demonstrate acceptability of the developed formulation and process.• Prepare, review and/or coordinate the execution of validation, commissioning and qualification documentation.• Ensure appropriate procedures, processes and policies are established and implemented for quality assurance activities to assure compliance with applicable medical device and/or biopharmaceutical regulations and products.• Work cross functionally with other groups to establish a program to collect and analyze product and process data to evaluate the state of control of the process/es.• Educate, train, advise and coach other employees to ensure adherence to all applicable quality standards for assigned areas

● Management Representative responsible for establishing and exerting an ISO 13485 and FDA 21 CFR 820 compliant Quality Management System.● Compilation of Design History Files and preparation of medical device regulatory applications forsubmission according to Quality System Regulations requirements.● Reporting directly to top management on the status of regulatory submissions.● Management of communications with regulatory agencies and test laboratoriesmanaging regulatory submissions, designing of pathways to market, and planning project verification and validation (clinical trials, safety and EMC testing) on behalf of the organization.● Generating quality management system documentation including policies, procedures,and records.● Participating in opportunities to develop regulatory and medical device business.● Review of marketing, packaging and labelling material to determine alignment with regulated product claims.● Person Responsible for Regulatory Compliance (PRRC) and of the quality management system as needed (e.g. risk management, change control, audits, CAPA, quality training of personnel, product design reviews, supplier qualification, equipment callibration).● Risk management lead per ISO 14971 throughout the product lifecycle.● Application of medical device international standards for product design and development (ISO 13485, ISO 14791, IEC 60601, IEC 62304, IEC 62366).

Management of research projects and scientific publications.Training of new students in biosafety level 1 laboratory techniques and animal handling.Development of research protocols and design of experiments. Statistical design and analysis of large amounts of data using Minitab and Microsoft Excel.Inventory management.Leading of engineering undergraduate students, and collaborating with cross-functional teams.Cell maintenance (freezing, media change, and banking) and characterization (confocal imaging, plate reader, microscopy, cell counting, antibody immunostaining, drug screening and video analysis).CAD design of microfluidic devices (Fusion 360 and SolidWorks).Microfabrication of microfluidic devices (micromilling and lythography).

Laboratory teaching assistant in charge of instructing and leading 20+ undergraduate students.Development of a tissue engineering platform for cardiac and muscular regenerative medicine.Primary cell culture.Cell culture media optimization and formulation.Animal handling and surgeries.Cell characterization (confocal imaging, microscopy, immunostaining and video analysis).Mechanical characterization of polymers.Polymer synthesis.Design of experiments.Statistical design and analysis.Experience designing and developing microfluidic and microfabricated medical devices.

Coordination and planning hospital visits.Contact with student homestays and hospital staff.Training of 10+ undergraduate engineer students in repairments and maintenance of medical equipment. Project and human resource management.

Regulatory assessment and negotiation with international manufacturers for the importation and distribution of medical devices.Preparation of budget, schedules, specifications, and technical documentation.Logistics and supply chain experience coordinating product deliveries and transportation.Market research and technical benchmarking of medical devices. Development of CAPAs, FMEAs and SOPs.Cooperation in ISO 9001 and ISO 13485 audits.Liaison between sales department, purchasing department, suppliers, and clients.Post-market surveillance after medical device sale.

Inventory management of medical equipment and instruments.Medical personnel training on medical equipment handling.Assistant to external field service engineers.