Product Development EngineerSr- Dev.

Company: Kinetic Concepts, Inc. Location: San Antonio, TX 78201 Status: Employee Job Category: Engineering Career Level: Experienced (Non-Manager) Company: Kinetic Concepts, Inc. Reference Code: IRC154503 Product Development EngineerSr- Dev.  Responsible for providing support and guidance to new product development teams to assure the quality and reliability of new products.  This position is responsible for ensuring the quality and reliability of new products through the appropriateness of design inputs, adequacy of verification and validation testing, and identification of key quality characteristics for the device. Bachelor’s degree minimum, Bachelors in Materials, Mechanical, Electrical, or Biomedical Engineering Eight years combined product development experience and quality engineering; medical device industry strongly preferred.  Experience in print and specification review Knowledge of Risk Assessment. Regulatory experience with UL and IEC standardsOther Qualifications   Six Sigma expertise demonstrated in manufacturing and design of new products Experience in GMP certified Manufacturing Processes and UL, IEC Standards. Ability problem solving skills, ability to diagnose issues, find and test solutions. Ability to communicate technical subject matter effectively, orally and in writing, to technical and non-technical audiences. Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude. Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment. Masters Degree Project Management Experience Experience with ISO 14971 preferred Experience in developing Software Requirements and conducting Software Validation.  Experience in a regulated design environment with medical device development highly preferred, FDA or ISO registered work experience.