Product development; Project management

Releasing new products to manufacturing and sale

 Evaluation  range of requirements for development in compliance with specific QMS and according to ISO 9001, ISO 13485, 21 CFR 820, and EN13060, EN ISO 14971 standards … etc. with conformity to MDD 93/42/EEC, CMDR ISO 13485, Japanese PAL. Managed troubleshooting and tests such as Life, Microbiology, Proof, FMEA, EMC/EMI, Software, Type, Margin, Dry … etc. insuring products conformances to standards such as on ISO 13485, JIS T 7324:2005, JIS C 1010-1:2005, IEC 61010-2-040:2005, JIS C 1806:2001, JIS Z 8737-2:2005, JIS T 14971:2003, EN 61010-1:2001, EN 61010-2:2005, EN ISO 14971, EN 13060:2004 A2

Assignment and control Mechanical, Software, Electrical, Hardware, Industrial, Quality engineers, Regulatory Department, Laboratories (EMC, Microbiology, Internal) and other project management peers, and provided leadership and mentoring in development of best practice project management systems. Performed Design to Manufacturing of plastic, metal, sheet metal..etc, parts and systems.

Liaisons with customers and evaluation, coordination, managing the main manufacturers. Fostering of innovative solutions to customer needs. The conceptualizing and day-to-day management of simultaneous projects.

Provided project management leadership/support to business development activities, as well development of life cycles, capital cost estimates, evaluation most suitable mass manufacturers and of alternatives. 

Incorporated safety, health, and environmental best practices and regulatory compliance into all engineering and project management activities, and ensures adherence to engineering principles, practices, and standards.

Development life cycles. Creation completing all technical files, documentations, drawings. 

Sustaining Engineering: Root Cause Analyses of Failures at Mass-Manufacturing of all existing products and Corrective, Preventive Actions (COPA, and QAP). Also, have proven track of results of resolution of long-term manufacturing problems.

Creation of set of regulatory tools for ongoing profitability analysis and drove profitability enhancements by new product line. One small project as an example: The savings of $160000 CAD had been achieved. 

Identification strategic new product lines and establishing partnerships with innovative OEM suppliers to commercialize disruptive, highly profitable new technologies 

Rejuvenated aging flagship product line such as STATIM 2000, 5000 Autoclaves, HYDRIMs family of washing disinfection machines   by drastically reducing the manufacturing annual failure rate from 6.45% to 4.14% by resolving numerous of long term problems (up to 19 years long) related to quality and processes: - http://www.scicancanada.ca/statim-g4?gclid=CNen9avFycsCFYKBaQodjU0JzQ, -  http://www.scicancanada.ca/hydrim-g4-c61w-instrument-washer

Identified strategic new product lines and established partnerships with innovative OEM suppliers to commercialize disruptive, highly profitable new technologies