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Subject: Medical Device Engineer, Cleveland, OH 3 Yrs. Minimum Experieince

Elyse Martin posted a job: Medical Device Engineer, Cleveland, OH 3 Yrs. Minimum Experieince

"http://www.lindahertz.com and/or send resume to myresume@lindahertz.com Medical Device Engineer-Wound Care (System Engineer, Mechanical Engineer or Electrical Engineer); a new Project Engineer opportunity centered upon engineering leadership to cross functional project teams. A market and world leading manufacturer and distributor of medical rehabilitation products, GREAT opportunity with a newer Division within the wound care market segment as they develop their second generation of medical device products! This leading medical device sales company conducts business in more than 80 countries around the world and is now looking for a Electrical, Systems, Bio-Mechanical or Mechanical Engineer with experience working with Change process and manufacturing within the medical device or bio-medical industries. The right candidate will provide project engineering leadership through final release of drawings and first product run and understand how to work with and lead cross functional project meetings, with timeline and deadline execution. The right person will ideally be from the industry and have experience with FDA 510K Pre-Market Submissions for Class II (Class 2) and Class III (Class 3) medical device products. Knowledge of Electrical Safety (UL Testing and Certifications, CE Testing and Certifications) and EMI/EMC standards preferred. In addition, ability to use 3D CAD to layouts and detail drawings to build medical device prototypes and convey design concepts to others. Must have a thorough knowledge of mechanical drafting, dimensioning and tolerance methods, as experience working on component/subassembly projects from concept to release. This is a ground floor opportunity within a large company umbrella and an exciting time to join and grow with their engineering team with room for advancement! If you like to generate new product and product improvement ideas with proven ability to provide engineering leadership to cross functional teams in an exciting environment this job could be for you! Essential functions of job are as follows: FDA 510K Pre-Market Submissions for Class II and Class III Medical Devices Software Validation Protocols UL Testing/Certifications, as well as CE Testing/Certifications 3D CAD Knowledge (layouts and detail drawings) Mechanical Drafting, dimensioning and tolerating methods MUST provide engineering leadership on moderately complex projects with cross functional teams and meetings Generating engineering specification after agreement with Marketing on functional specifications Project Management with timeframes and deadline execution (taking ownership of the process and outcome) Generate new product and existing product improvement ideas (engineering support to current line). Working with outside vendors and third party teams (co-partner's)"

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