Senior Design Engineer (Medical Device)

TDC Medical is a full-service provider of medical device design, product development, and manufacturing services. We help medical device companies bring products to market quickly and cost-effectively.

Title:Senior Design EngineerPosition Summary:

We are seeking a high-performing individual to participate as a team member in designing and developing medical devices from concept through market introduction on a contract basis for client companies. The desired individual will possess a broad range of medical device design and development skills and experience, as well as depth of knowledge in several clinical, product and technical areas. The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, entrepreneurial environment.

Essential Duties and Responsibilities:Contribute to the design and development of medical instruments (disposable and reusable), catheters, implants, and/or packaging, from concept through market introduction and design for manufacturing. Utilize SolidWorks or Pro-E to develop designs, detailed 3-D CAD models and drawings of medical instruments (disposable and reusable), catheters, laparoscopic devices, implants, and/or packaging. Includes component, subassembly, and top-level drawings.Produce prototype devices for testing, and for evaluation by client companies. Produce or obtain prototype device components. Assemble and evaluate prototype devices.Prepare documentation release packages, including detail drawings, bills of material, and/or procedures.  Prepare Document Change Orders (DCOs) to release documentation.Specify and purchase components, equipment, materials and supplies. Identify and interact with vendors.Design and construct manufacturing tooling and fixturing.Conduct product verification and validation testing to demonstrate product safety and efficacy. Develop protocols, plan testing, and perform testing. Write test reports which draw conclusions from the results.Ensure that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.Required Education, Experience, Skills and Knowledge:Bachelor's degree in Mechanical or Biomedical Engineering is desired.Minimum of 5 years of medical device product design and development experience is required.Demonstrated ability to bring products from concept to market.Ability to interact with client companies in a professional manner.SolidWorks or Pro-E 3D CAD proficiency helpful, but not required.Familiarity with FDA QSR and ISO 13,485 medical device regulations.Knowledge of probability and statistics.Knowledge of geometricd dimensions and tolerancing.Depth of knowledge in one or more clinical and product areas.Depth of knowledge in one or more technical areas, for example finite element analysis.Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.

 

To apply for this position please email your resume to careers@tdcmedical.com