Job Description & Skill Requirement:
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Lead new product introductions and ensure successful transition to manufacturing
• Provide manufacturing engineering support for the development and manufacturing of new products
• Evaluate proposed designs for manufacturability and provide DFM recommendations
• Develop and establish robust, repeatable, and reproducible processes
• Represent manufacturing engineering in cross-functional teams
• Perform process validations (IQ/OQ/PQ)
• Monitor, evaluate and report project progress and results
• Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of
projects in progress on a regular basis
• Perform root cause analysis of product/process issues and implement short and long-term corrective actions to
improve product quality
• Prepare technical and validation protocols, written reports, documentation, and engineering change notifications
• Provides technical supplier management support as related to product development and introduction
• Analyze and plan work force utilization, space requirements, and workflow and designs layout of equipment and
workspace for maximum efficiency.
• Confer with vendors to determine product specifications and arrange for purchase of equipment, materials or
parts and evaluate products according to specifications and quality standards
• Estimate production times, staffing requirements, and related costs to provide information for management
decisions.
• Confer with management, engineering, and other staff regarding production capabilities, production schedules,
and other considerations to facilitate production processes
• Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure
compliance to FDA, cGMP and all other applicable agency regulations
LEADERSHIP RESPONSIBILITIES
• Lead functional and cross-functional teams to achieve project goals.
• Mentor junior manufacturing engineers in project management activities
EDUCATION AND/OR EXPERIENCE
• Bachelor's Degree or higher in biomedical, mechanical, industrial or similar discipline
• Minimum of five (5) years related experience in FDA/GMP regulated industry.
• Proficient in SolidWorks, Minitab, Word, Excel and Project
• Experience in product development and manufacturing methods, procedures, and cost reduction/yield
improvement techniques
• Background in medical device assembly, automation, and vision system technology
• Experience in the application of statistical techniques such as statistical process control, design of experiments,
and problem-solving techniques is required
• Experience with design, review, execution, and approval of Installation, Operation and Process Qualification
protocols and reports (IQ/OQ/PQ)