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Job Title: Product Design Engineer (Job # 3644) | Apply Now
Job Description: Medical Product Design

Responsibilities:
Product Design Engineer: Product Design/Re-Design. Prepare/Review drawings . Materials and manufacturing. Quality Control. Drawing Control. Filing. Create process documentation. Technical Assistance. QUALIFICATIONS: Minimum of 4 year technical degree (BS/ME preferred) or similar work experience. Knowledge of manufacturing assembly, Quality Assurance, machine shop, plastics, metals, materials. Knowledge of DOE, FMEA and Risk Management processes. Knowledge of Microsoft Office at an Intermediate or higher level. Knowledge of Trigonometry, Geometry and Algebra MUST have knowledge of ISO 13485 or 9001 DUTIES PERFORMED Product Design/Re-design Develop product concepts following specific Design Control procedures per ISO and FDA utilizing processes such as DOE and FMEA, amongst others. Perform Risk Analysis Measure design inputs against design outputs Meet with and review potential/current suppliers to assess capabilities, etc. Define Test Protocols and Acceptance Criteria Research new product technologies Prepare/Review drawings : 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. Direct necessary changes to improve drawing completeness Assist Instrument Department with necessary information, details, tolerances, etc. for drawing completeness. Materials and Manufacturing: Define manufacturing protocols. Define material specifications Develop project GANTT charts to meet objectives. Troubleshoot and resolve challenges in existing products. Prototyping. Design/Develop Fixtures to aid in assembly and production. Quality Control: Assist with Quality control of products before shipping Assist Quality Assurance Manager to comprehend quality related issues and to be involved on resolution team. Assist with defining Quality Control Criteria Define and Assist with First Article Inspections Drawing Control: Maintain drawings within the Device Master Record (DMR) Maintain Drawing Access System for CAD Files Revise drawings using the Document Change Request (DCR) process Maintain non-released drawing control for both Hard Copy and Electronic drawings. Filing: Information via journals, magazines and books; completed projects, prototypes, supplies and notes are filed for access at a later date. Ongoing projects also have a file folder. Utilize the Archive system Create process documentation: Create formal process documentation such as Work Instructions (WI), Inspection Procedures (IP), Manufacturing Procedures (MP) Institute and document operating procedures. Create and maintain records and files that comply with GMP and ISO Requirements such as Device Master Record (DMR), Device History File (DHF), Design History Record (DHR) and Technical Construction Files (TCF). Technical Assistance Supply Regulatory department with technical assistance for Regulatory Submissions and inquires.
Competencies/Experience:
Experience: 5+ years work experience as a Product Designer utilizing Design Control Procedures with Medical Devices (in an ISO 13485 or ISO 9001 certified company) required. 5+ years Project Management experience with Medical Devices required. 3+ years experience with AutoCAD 2000 or higher. 4+ years experience with Solid Works
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