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2221 Washington St.
Grafton, WI 53024

Toll Free: 866.546.0010

Direct: 262.546.0010

Fax: 262.546.0011

Product Development Engineer

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.
• Participates and/or leads cross-functional teams.
• Provides technical support on components, materials, and equipment.
• Assists with capital equipment research and plant layout.
• Creates, reviews and approves protocols, reports, data and business correspondence.
• Maintains a professional working relationship and effectively communicates with 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 Engineering or Biomedical Engineering with mechanical emphasis; minimum of three years of progressive experience in the development of medical devices; or equivalent combination of education and experience.
• Proficient technical skills; knowledge of manufacturing processes, FDA design control activities and design history files; techniques for maximizing the effective manufacture of goods; experience generating and checking technical documentation such as design drawings, risk analysis, SOP’s and test reports.

 

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Gauthier Biomedical is an equal opportunity employer.