This job description is for an Associate CAD Designer in the medical device field.

• The Associate CAD Designer reports to the Product Development Manager-PSI and is responsible for collaborating on conceptualization, application, development, design, and manufacturability of Company medical implants and instruments. 
• The position will utilize the documented design and development process procedures, quality metric data, mechanical testing, sound scientific methods and risk analysis to assure quality is instilled into the product and process designs. 
• This position works across all departments and business units of the company such as Reseach & Development, Operations, Supply Chain, and Quality to help assure design and development process consistency, bench marking for possible product and process design improvements as well as design and development compliance. 
• The Associate CAD Designer will provide technical support to the Product Development Manager-PSI for assigned product development projects. The Associate CAD Designer provides input to develop Company medical products and applications by communicating with the Product Development Manager-PSI, Director of Research & Development and the Quality Department, utilizing stakeholder inputs. 
• The position has working knowledge of 21 CFR Part 820 and ISO 13485 and related design and risk guidance documents so it is applied in daily work activities. 

The following is a list of duties for the position of the Associate CAD Designer: 

• Collaborates on cross-functional teams representing Research and Development, Engineering/Product Development 
• Ability to use engineering analysis and design tools such as parametric and direct modeling computer-aided design (CAD), in order to design and evaluate new products 
• Create CAD drawings from hand sketches, written/verbal instructions, and web-based design sessions 
• Seamlessly integrate and work with project managers, customers, and manufacturing suppliers to produce and gather input for updating drawings 
• Create and continually update project models and drawings in addition to maintenance of related Design History Files (DHF) 
• Supports the evaluation of non-conforming material and complaints by supporting root cause analysis, related to design, per the Investigation Procedure
• Initiates Design for Manufacture (DFM) reviews with suppliers to obtain early feedback on the feasibility, manufacturability, and reproducibility of a design and documents the results as part of the DHF 
• Initiates cross-functional Design Reviews based on Design and Development Procedures and documents results as part of the DHF 
• Assist in release of ECOs for new or modified drawing specifications, protocols and procedures related to the Engineering function 
• Helps to author corporate procedures to improve upon the quality system as it relates to the design and development process 
• Collaborates with the Product Development Manager and Quality to identify Critical-to-Quality (CTQ) Specifications and helps to establish acceptance criteria for inspections and associated activities 
• Ensure that products are promoted in compliance with the FDA approved indications for use 

EDUCATION REQUIRED: 

• Associate’s degree in CAD technology or drafting 
• Bachelors’ degree in engineering with CAD emphasis 
• Certificates in 2D/3D CAD, medical segmentation, or computer-aided manufacturing (CAM) preferred 
• 2 years experience in a CAD drafting role 

ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS REQUIRED: 

• Experience in design, development and commercialization of Class I-II-III medical devices 
• Experience in using CAD packages such as: Dassault Systemes SolidWorks, 3DSystems Geomagic Freeform and Materialise 3-Matic  Experience in using medical segmentation packages such as: 3DSystems D2P and Materialise Mimics 
• Experience and understanding of risk analysis as inputs to the product and process design
• Familiarity with regulations and standards for the design and development of implantable medical devices 
• Ability to interpret device regulations and standards into efficient and effective practices and procedures 
• High attention to detail: work must be accurate and complete 
• Ability to make independent decisions, but benchmarks and communicates regularly with other design and development functions and suppliers 
• Works well in a team environment 
• Ability to adjust priorities as required by the needs of internal and external customers 
• Ability to systematically approach issues and opportunities for robust solutions 
• Ability to handle conflict and present data driven recommendations 
• Excellent technical writing skill and ability to communicate well (both written and verbal)  
• Must possess project planning and management skills 
• Ability to meet deadlines and/or objectives as directed 

All your information will be kept confidential according to EEO guidelines.