Ofer Cohen Email & Phone Number

Israel

- Responsible for Product Development of the company’s line of Endosurgery Catheters and supporting medical devices.- Lead a multi-disciplinary team of ~20 as well as external sub-contractors (strategy and tactics, professional guidance and personal development). - Annual budget of ~$1.5 Million.- Close coordination with PM of project timelines, budget, and allocation of resources.- Participate in the development and implementation of quality assurance and quality control activities- Oversee and sign-off on all Design Verification and Validation activities, risk management, and DHF in general.- Participate in customer/regulatory audits in close cooperation with QA and RA- Establish and maintain effective working relationships with business partners, vendors, and customers.- Lead cooperation between all teams involved: engineering, marketing, purchasing, operations, tooling, manufacturing, QA/QC, regulations, over-seas production, and distribution. - Work closely with companies including Ethicon (J&J), Medline, Medtronic, BD Bard, Fresenius, Cardinal Health…

- Product Development Manager and life cycle support for the company’s residential mechanical water meters and electromechanical registers. Initially team of 3, concluded with team of 13.- Managed product direction with international and local marketing and sales teams, and supported customer relations.- Supervised the V&V, Prototyping, and Environmental Testing Labs.- Lead seamless cooperation between all teams involved: engineering, marketing, purchasing, operations, tooling, manufacturing, QA/QC, regulations, over-seas production, and distribution. - Worked closely (including frequent on-site presence) with production sites spanning USA, Germany, China, Mexico, France, Portugal, Spain, and Sweden.

- Managed complete product development of a neuro-prosthesis system intended to restore walking abilities specifically for children.- Program Manager (matrix management) of a multidisciplinary team of ~40 members, including clinicians, international marketing, industrial and mechanical design, purchasing + NPI, operations, tooling manufacturers, QA/QC, regulations, clinical testing, and over-seas production.- Responsible for budget oversight and on-time delivery to market of a complex medical product, including close support of the FDA and CE approval process, as well as Chief Scientist Grants.- Executed transfer of production from Israel to China within 3 months, with no disruption to quality and sales.

- Physical product development manager of a full QWERTY keypad accessory for the miniature phone, in close cooperation with the HW Team.- Managed and monitored development and production processes of overseas subcontractors (ODM), including delivery of detailed assembly and tooling SOP plans.

- Two year project for GIVEN IMAGING (Medtronic) as Project Manager and Team Leader (with Aran R&D) for the development of a portable data recording system for the company’s “PillCam”, including portable recorder, sensor array affixed to the patient’s body, desktop docking station, and carrying case.- Four years at MOTOROLA as Mechanical Designer and CAD Assembly Manager of ruggedized radios, mobile phones, and PDA’s, for security forces and government authorities.- Additional Clients included: ARAN R&D, ATTENTI (DMATEK), KETER, and more.

- Product development from concept to manufacturing in a variety of industries and with numerous clients, including Nisko, IDF, Hamat, Odin, TransScan, Bluesoft, SenseIt, Anorad, and more.

- Design and engineering of storage and kitchen ware for Keter Plastics.

Bsc + Minor, Product Design + Business Management

First Year Mechanical Engineering

Education record