Kurt Albertson Email & Phone Number

Burlington, Massachusetts, Us

Position responsible for Design Transfer; develop and transfer products to manufacturing, Lead the design transfer of manufacturing and inspection processes and develop manufacturing processes, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity, Lead all process validation activities (execution of IQ/OQ/PQ);Process Support and Improvement; Lead investigation, with Manufacturing Engineering and Quality, into production issues to improve production throughput and yields, leading edge of new processes, approaches, techniques, internal processes and requirements, Develop processes for prototype and pilot production of new products, product changes, and enhancements in coordination with R&D and Quality functions.

Contract technical services for medical device applications. Experience with startup and medium/large medical companies as well as venture-funded companies.Medical device process development to full manufacturing including execution of facility and yield improvements, and validation activities; specifically, PC, IQ, OQ, and PQ, to comply with FDA CFR 820, ISO 14385, and cGMP requirements. Able to expedite the introduction of a medical device from concept to market, ensuring safety, quality, and regulatory compliance.

Devens, Massachusetts, Us

Position responsible for developing and implementing operation and quality plans, procedures for suppliers, manufacturing, new product development, and quality assurance.

Minneapolis, Mn, Us

Engineering position supporting introduction, start-up and ramp of a new Neuromodulation product (InterStim™).Implemented Manufacturing and Test Design/Development/Production equipment/process including execution of Process Validation activities within the Medical Device Product Development Process, specifically PC, IQ, OQ, PQ, to comply with FDA CFR 820, ISO 14385, cGMP requirements. Led facility upgrade (ISO Class 8), CAPEX/OPEX expansion (2x), yield improvement (20 to 90%) and cost improvements that met aggressive market introduction goals. Responsible for technical support of a three shift, six-day operation. The technology utilizes implantable leads with a neurostimulator to provide electrical nerve stimulation therapy for therapeutic solutions to serious clinical conditions including nerve stimulation for pelvic disorders (InterStim™ Micro) and deep brain stimulation (DBS) treatment for Parkinson's disease (Sensight™).

Abbott Park, Illinois, Us

NPI position supporting the new HeartMate 3™ implantable left ventricular assist device, or LVAD. Responsible for developing and implementing manufacturing plans to accomplish a robust design transfer to production which included a close collaboration with R&D from design through initial concept to full production including; process (and vendor) development, coordinating multiple, sequential production processes and transferring those processes to production. Areas of expertise include; process selection, characterization, optimization and validation (IQ, OQ, PQ); DFM/DFA, risk analysis, costing, capacity and process control strategies.HeartMate 3™ implantable left ventricular assist device provides circulatory support for advanced heart failure patients, designed to restore blood flow, improve survival and quality of life.

Abbott Park, Illinois, Us

Engineering position devoted to the transfer of the OPTIS™ product line from concept to full production that involved a new facility and full production ramp in 8 months. Developed innovative assembly processes that increased yields to 95% , reduced lead times and strengthened Abbott's market position. Led cross-functional teams to transfer processes to production, developed solutions to product defects and implemented process improvements that increased output and improved quality.The technology involves new catheter based medical device (OPTIS™ system) that provides internal visualization for the cardiologist towards the successful dilatation and stent placement of occluded (blocked) coronary vessels.

Us

SRU Biosystems, a biotechnology firm, developed and commercialized the BIND® optical instrumentation system that enabled biochemical and cell-based assays for drug discovery and life science applications. Responsible for developing requirements, defining project plans, driving and coordinating execution and delivering on schedule, design and installation of microplate and microarray assembly and coating processes from prototype to commercial operation.