Manufacturing Engineer

TDC Medical, Inc.

Position Title:  Manufacturing Engineer

 

 

Reports to:

Program Manager

Location:

Marlborough, MACompany Overview:

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.Position Summary:

We are seeking a high-performing individual to participate as a team member in developing and manufacturing 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:Provide manufacturing based design input to product development team.Develop assembly methods, fixtures and tooling to manufacture medical devices. Develop and conduct equipment installation and qualification studies.Participate in verification and validation of product design and assembly methodsMaintain detailed documentation throughout all phases of product development and manufacturing. Work from and provide input to project plans that specify project phases, tasks, durations and costs. Work with mechanical designers to create new designs with proper documentation Participate in risk analysis for products under development. Operate computer, laboratory and manufacturing equipment to test and develop prototype product and assembly methods Coordinates activities with outside suppliers to ensure delivery of supplies or services needed to meet scheduled timelinesRequired Education, Experience, Skills and Knowledge:Bachelor's degree in Mechanical or Biomedical Engineering is preferred.  Equivalent work experience will be considered. Minimum of 5 years of medical device product design and development experience is required. Ability to interact with client companies in a professional manner. SolidWorks 3D CAD proficiency helpful, but not required. Familiarity with FDA QSR and ISO 13,485 medical device regulations. Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.

 

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