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POSITION SUMMARY
The Product Engineer works directly with the Engineering Manager and is responsible for developing and testing new products in accordance with customer needs and regulatory requirements. The Product Engineer is responsible for design process, material and sourcing investigations, product cost analysis, validations and initiating corrective action.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Manages customer product inquiries, product changes, and new product development
Assists with product submittals to FDA and regulatory agencies.
Writes and approves Document Change Orders (DCO)
Evaluates design, sourcing or manufacturing problems and initiates process improvements
Writes design and process validation protocols and results
Assists in researching design or process related issues and provides process and design improvements.
Writes and approves part and product specifications
Develops and approves new drawings, work instructions, test methods, risk analysis and Bill of Materials (BOMs).
Develops and maintains the records for Design History files (DHFs)
Estimates and initiates design and process solutions to reduce product and manufacturing costs
Participates in maintaining the companys quality management system, regulatory requirements, supporting product standards and adheres to standard operating procedures as applicable
Performs other duties as assigned
WORKING ENVIRONMENT
Indoor work within office and cleanroom environment
Routine use of standard office equipment and test equipment
Occasional travel for supplier and customer visits, training opportunities, etc.
KNOWLEDGE, SKILLS AND QUALIFICATIONS
Bachelor of Science degree in an Engineering field or related degree
Understanding of ISO 13485 and FDA regulations required.
Strong communication skills and computer proficiencies necessary, including Microsoft Word, Excel, Access and Outlook.
Experience with CAD software and reading print specifications.
Lift, carries or moves objects up to 25 pounds
