Posted OnMay 8th
n this role, the individual is primarily responsible for developing, maintaining, scaling, and improving the manufacturing processes for medical devices and other advanced biomaterials.
Duties and Responsibilities:
• Development and improvement of manufacturing processes by studying product requirements; researching, specifying, modifying, and testing manufacturing methods as required.
• Specification, justification, procurement, and qualification of process equipment to enable achievement of production objectives.
• Improve manufacturing efficiency by analyzing and planning workflow, labor requirements and costs, space requirements, equipment layout, and material costs.
• Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
• Keep equipment operational by coordinating maintenance and repair activities; following manufacturer’s instructions and established procedures and requesting special services as required.
• Train manufacturing staff as required.
• Ensure the quality of all products produced for commercial distribution domestically and internationally.
• Maintain proper cleanroom controls and aseptic handling techniques to ensure product cleanliness.
• Support the establishment and performance of Quality Engineering processes related to the manufacture of products (e.g., process risk analyses, process validations, sampling plans, statistical process control (SPC), supplier qualifications, and training compliance).
• Assist with the development and execution of production scale-up activities required to support product submissions to regulatory agencies or contract manufacturing opportunities.
• Act as the Manufacturing representative for the product development team by providing guidance and expertise in the areas of process scaling, pilot production, inventory and capacity planning, work instruction development and process costing.
• Be a primary user and subject matter expert in the use of Enterprise Resource Planning (ERP) software to achieve production goals.
• A Bachelor’s degree in Engineering is required. Specific degrees in Industrial, Manufacturing or Mechanical Engineering are preferred.
• Experience with batch manufacturing of chemicals, beverages or other processes that involve mixing and/or chemical transfer is highly desirable.
• Experience in manufacturing medical devices, pharmaceuticals, or laboratory reagents in a Good Manufacturing Practices (GMP) environment is desired.
• Experience with process validation, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) and process failure modes and effects analysis (PFMEA) are desired.
• Experience working in cleanroom environments is highly desirable.
• Strong written and verbal communication skills, with the ability to work closely with both internal and external team members.
• Proficient in the use of personal computers, including the use of Microsoft Outlook, Microsoft Word and Microsoft Excel.
• The ability to make necessary decisions and/or take action required to carry out job duties.
• Experience with Enterprise Resource Planning (ERP) software is highly desirable.
Salary Range: $50,000 – $70,000