ITC and Accumetrics are leaders in the development and manufacturing of Point-of Care blood testing and antiplatelet therapies. We are committed to developing, manufacturing & marketing safe, easy to use, & reliable products that are used by doctors, nurses & medical practitioners where care is provided to patients. We currently have openings for Quality Engineers in our San Diego location.
The Manufacturing Engineer II is responsible for technically supporting the medical device manufacturing operation. The Manufacturing Engineer II works to support new product design, develop manufacturing processes and prepare for new product transfer. The Manufacturing Engineer II also supports daily production operations and process and product improvement activities.
•Participate in design reviews for new product design and development; ensure designs meet requirement specifications
•Review all product documentations and ensure design manufacturability
•Design and develop manufacturing plan, processes, testers, fixtures and equipment
•Participate in vendor and supplier qualification processes; ensure capability to meet company’s quality standards, technical requirement specifications and supply demand
•Support installation, qualification and validation of new equipment and processes; write and execute feasibilities, protocols/reports and standard operating procedures (SOPs)
•Provide troubleshooting, failure analysis and training for staff
•Create/implement programs for volume demand increases, cost reduction, quality and efficiency improvement
•Resolve technical issues with vendors and suppliers
•Resolve electronic parts obsolescence and Restrictions on Hazardous Substances (RoHS) / Waste of Electrical and Electronic Equipment (WEEE) component engineering issues; drive and coordinate activities to make all active manufactured instruments RoHS/WEEE compliant (Electrical Engineer specific)
•Establish a safe, secure, controlled and efficient operating environment
EDUCATION AND EXPERIENCE:
•Bachelor’s degree (Mechanical or Electrical Engineering) required
•Three (3) to five (5) years previous manufacturing or engineering experience; experience within a medical device environment desired
•Must be familiar with Food and Drug Administration (FDA) good manufacturing practices (GMP) requirements, ISO 9000 Standards and Occupational Safety and Health Administration (OSHA)
•Must be competent in writing and performing validations in a GMP and ISO9001 regulated environment; statistical analysis and sampling experience preferred
•Must be technically proficient in creating and understanding engineering drawings, schematics, specifications, tolerancing and bills of materials
•Excellent written and verbal communication skills are essential
•Excellent project management and problem solving skills are required
•Computer literacy required; knowledge of Microsoft Office and experience with large enterprise resource planning (ERP) system preferred
•Must be proficient in Solidworks or OrCAD
•Must be comfortable with automation development (batch and continuous methods)
•Knowledge of PLC, vision, reagent filling/dispensing, injection molding, drying, printing, pouching, and packaging desired
•Must be self-motivated and have the ability to work with minimal supervision; must also be able to work as part of a team
•Problem solving skills; ability to recommend and/or implement timely solutions
•Ability to consistently produce accurate results, meet established quality standards in a timely manner
•Ability to make effective and timely decisions and recommendations
•Ability to deliver on commitments and to meet deadlines; accountability
•Ability to create quality and efficient improvement program
•Adaptability; demonstrated flexible work behaviors and ability to manage change effectively
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means shall be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
If you have a passion to make a difference, while improving the health and well-being of people around the world, we want you. You will have the opportunity to collaborate on challenging projects with peers that possess intellect, integrity, and pride in what they do. It means succeeding in making a difference in the lives of others. We continually seek and encourage others who share this same passion in making a difference to join our team. We offer great benefits and we are located in the Sorrento Valley area.