Engineer
Current• Responsible for the design control of an electronic, physiological pressure measuring device, with 5 different SKUs, selling 300,000 units annually. Daily responsibilities are not limited to, compliance to domestic and international standards, IQ/OQ/PQ for design changes, Test Method Validation (TMV), complaint investigation, risk identification/mitigation, continuous improvement, manufacturing, quality control support, cost improvement, supply chain interruptions, vertical integration.• Accountable for all Custom Extension Sets, 2000+ SKUs, bonding validations, ISO Compliance, CE certificates, complaint investigation, real-time & accelerated aging, risk identification/mitigation, and material substitutions for dual sourcing, or supply chain issues.• Conduct Installation Qualifications (IQ), including software validation, on all injection molding equipment/components and ancillary equipment such as chillers, thermolators, resin dyers, moisture analyzers. Additional equipment IQ's include adhesive dispensers, overs/environmental chambers, imaging systems, pneumatic slitters, tipping machines, skiving machines, and pad printers. Often calibration, operating, and maintenance procedures/forms are created as a part of the IQ.• Successfully led the submission process for CE marking of a Class IIa medical device, including preparation of technical documentation, risk management files, clinical evaluation reports, and conformity assessments, resulting in approval by a Notified Body and market entry in the European Union.• Collaborated with cross-functional teams, including R&D, regulatory, quality assurance, quality control, and manufacturing, to design and develop innovative medical devices, ensuring compliance with FDA and ISO standards while optimizing product performance and patient safety