We are searching for a talented development engineer to work for our client in Sugar Land, Texas. They design and manufacture specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries.
Job Summary:
The Development Engineer is responsible for the design and development of new products and the evolution of existing products. Primary areas of responsibility include Design Feasibility Activities, Design Control and Risk Management Activities, Design Verification/Validation Activities, Bench Testing, and constructing Design History Files and Risk Management Files in accordance with Quality System Documents. The Development Engineer should have great attention to detail, as they will be involved with key tasks related to TSI's product quality and safety. The Development Engineer works with a cross-functional project team consisting of design engineers, quality engineers, RA/QA, product managers, project manager, and sales.
Experience/Skills:
? Good task and time management skills with the ability to work on multiple development projects simultaneously
? Full working knowledge of and experience with new product development in the medical device industry
? Excellent communication skills in order to interface with internal and external cross functional team members including Manufacturing, Engineering, Regulatory, Quality, Product Management, Project Management, Marketing, and Sales
? Strong technical writing skills
? Prior design experience using SolidWorks. Working knowledge of drafting standards and geometric dimensioning and tolerancing
? Experience with Medical Device industry standards preferred, such as reprocessing validation, packaging validation, human factors, risk management, etc.
? Strong working knowledge of Design Control, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP)
? Experience executing verification and validation testing, and documenting test procedures and reports
? Ability to process customer complaints, engineering changes, and nonconforming product
? Demonstrated good written and verbal communication skills including presentation skills
? Assure preproduction quality requirements are met
? Creating detailed, comprehensive and well-structured test plans and test cases
? Estimating, prioritizing, planning and coordinating quality testing activities
? Proficient in Microsoft Office Suite
Required Education/Licensing/Certification:
? Minimum 3 years engineering experience in the medical device industry, with a minimum of 2 years' experience in medical device product development.
? Technical writing, research paper writing, and/or experimental design experience.
? Minimum Bachelor of Science (B.S.) degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical or Biomedical Engineering or a related subject.