What are the responsibilities and job description for the Product Development Engineer position at Gauthier Biomedical Inc.?
Summary: Develops, designs and documents new and improved medical device instruments and provides engineering support in research, verification, validation, manufacturing and testing of products.
Essential Duties and Responsibilities:
- Generates design output in the form of material specifications, 2-D engineering drawings and 3-D models in Solidworks that are manufacturable, creative, cost effective and robust.
- Designs instruments to customer specifications, industry standards, quality and regulatory requirements; especially FDA and ISO design controls.
- Provides support to manufacturing and quality to aid in solving problems; ability to isolate variables affecting performance of instruments using Design Of Experiments (DOE) techniques.
- Generates design verification and validation test protocols, and coordinates those activities.
- Provides accurate and timely technical support on components, materials, and equipment.
- Creates, reviews and approves protocols, reports, data and business correspondence.
- Applies continuous improvement methods to enhance manufacturing quality, reliability, and/or cost-effectiveness.
- Performs other assignments as necessary.
- Maintains a professional working relationship and effectively communicates with all employees, managers, vendors, customers and regulatory agencies.
- Understands and complies with company policies and procedures, regulatory requirements and safety regulations.
- Regular attendance at work is required.
Qualifications:
- Bachelor’s Degree in Mechanical or Biomedical Engineering or related Bachelor’s Degree; minimum of three years of experience in the development of medical devices; or equivalent combination of education and experience.
- Proficient technical skills; knowledge of manufacturing process techniques to maximize production; experience generating and checking technical documentation such as design drawings, risk analysis, SOP’s and test reports.
- Experience with 3D Computer Aided Design CAD software; Solidworks experience preferred.
