Development Engineer, Design History Files/Design Controls, Medical Device

Company: GForce Life Sciences
Location: Toledo
Posted on: March 26, 2020

Job Description:

GForce GForce Life Sciences is a consulting firm that provides leadership and teams to some of the world's leading pharmaceuticals, medical devices, & diagnostic manufacturers, middle-market clientele, and recently funded startups. Headquartered in Chicago with a nationwide presence, GForce has successfully completed countless engagements for clients ranging from Fortune 500 to startups. Summary Our client, a global medical device firm, has engaged GForce Life Sciences to provide a development engineer to join their team and will be responsible for the design history file effort by performing a full gap analysis of the design documentation of products. Will assist with the design, development, and processing of products. Will work on the development of new products and maintenance of existing products. Duties / Expectations of RoleIdentifies all tasks required to complete project assignments according to Design Control procedures. Assists with the development of new products and manufacturing processes. Prepares work plans outlining estimated manpower requirements and development costs. Recommends project budget and schedule to carry out programs on a timely basis. Designs for reliability, regulatory compliance, manufacturability, inspectability and optimum cost Participates in root cause analysis for problem-solving Contributes to the generation of a comprehensive protocol for testing/analyzing the product Prepares definitive new product specifications or modifies existing specifications Generates or updates design assurance documentation for the product Generates and/or manages the creation of prototype models to evaluate new design concepts Responsible for collecting and assessing existing design documents, and to perform a gap analysis of the DHF/Design documentation based on current regulatory agencies' guidelines regarding design control. Review (for accuracy and completeness) verification and validation data, including reports, spreadsheets, statistical summaries, for incorporation into project documentation. Mandatory RequirementsEngineering degree or equivalent (Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering, or Aeronautical Engineering). Minimum 3-5 years of experience in Design and Development related position either in development or R&D department in an FDA regulated Industry. Full working knowledge of and a moderate level of experience with new product development in medical devices Demonstrated ability to methodically investigate, determine appropriate solution and resolve problems using current technology Ability to develop a project schedule and assess cross-functional team's progress on assignments relative to project schedule Ability to process engineering changes and make recommendations based upon business principles Professional, concise, tactful and sensitive in communications. Accomplishes objectives when communicating with internal personnel, and external customers and vendors. Demonstrated good written and verbal communication skills including presentation skills Working knowledge of drafting standards and geometric dimensioning and tolerancing Fluency with Creo, SolidWorks, and AutoCAD Must be familiar with current Design Control guidelines. Team player (displays enthusiasm, confidence & commitment). Microsoft Office Suite and Project Ability to take initiatives and work independently. Term & Start-- 12-month engagement. -- Unfortunately, remote work is not an option for this engagement.

Keywords: GForce Life Sciences, Toledo , Development Engineer, Design History Files/Design Controls, Medical Device, Healthcare , Toledo, Ohio