Details: We have been engaged by our client to recruit for their Product Designer / Engineer position. Our client is a leading medical device company located inSt. Paul. This Product Designer / Engineer position is responsible developing product concepts following specific Design Control procedures per ISO and FDA utilizing processes such as DOE and FMEA. Ideal candidates will have 5+ years of experience as a Product Designer within the medical device industry. Local candidates only as the company will not provide relocation assistance. Responsibilities: Develop product concepts following specific Design Control procedures per ISO and FDA utilizing processes such as DOE and FMEA, amongst others. Coordinate Product Development team to support new/re-design products. Author and coordinate Risk Management activities. Meet with and review potential/current suppliers to assess capabilities, etc. Author test protocols and acceptance criteria including Product Validation testing. Perform said testing for final approval. Research new product technologies for review/discussion. Prepare/ Review drawings for engineering, production, and quality control as requested. Prepare/Review prototype drawings as requested. Prepare / Review drawings of existing product to document product specifications as requested. Define manufacturing protocols. Author and perform Process Validations for final approval. Define material specifications. Troubleshoot and resolve challenges in existing products. Assist with Quality Control of products before shipping. Assist Quality Assurance Manager to comprehend quality related issues. Investigate product complaints, make recommendations for final determination. Maintain drawings with the Device Master Record Maintain drawings Access System for CAD files Create formal process documentation such as Work Instructions, Inspection Procedures, and Manufacturing Procedures. Implement and document operating procedures. Create and maintain records and files that comply with GMP and ISO requirements such as Device Master Record, Device History File, Design History Record, and Technical Construction Files. Supply Regulatory department with technical assistance for Regulatory Submissions and inquiries. Qualifications: Minimum of 4 year technical degree (BS, ME preferred) 5+ years work experience as a Product Designer utilizing Design Control Procedures with Medical Devices ISO 13485 or ISO 9000 certified required. 5+ years experience on Product Development teams with Medical Devices required. 3+ years AutoCAD 2000 or higher preferred. 4+ years experience with Solid Works required. Print reading ability, ability to figure out auxiliary views, multi-view sketching or drawing. Ability to use calipers, micrometers, gauge pins and optical comparator. Hudson IT serves as a trusted resource for clients seeking high-quality technology professionals and IT solutions. We seek consultants and direct candidates with diverse skills and industry experience – from Java developers in financial services to Epic consultants in healthcare. From instructional designers to QA experts and everyone in between, we attract the best and the brightest talent in the industry, matching your skills and personality to our clients’ specific requirements. Known for our exceptional service, Hudson IT has been recognized in the top 1% of staffing firms for client and candidate satisfaction three years running. Learn more at us.hudson.com/it. Hudson (www.hudson.com) is an Equal Opportunity Employer. We participate in the E-Verify program as allowed under federal and state law and in accordance with our executed Memorandum of Understanding with the Department of Homeland Security.

View the original article here