Manufacturing Engineer II

Responsibilities

• 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 and failure analysis.
• 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.
• Prepare reports as needed.
• Advance knowledge of scientific and engineering principles.
• Ensure and maintain compliance with the company's quality system requirements through training and adherence to policies, procedures and processes.

Qualifications

• Bachelor's degree (Mechanical or Electrical Engineering) or equivalent years of experience.
• Three (3) to five (5) year previous manufacturing engineering experience; previous experience within a regulated medical device or pharmaceutical environment preferred.
• Good understanding of manufacturing, automation, and sustaining engineering concepts.
• Techically proficient in creating and understanding engineering drawings, schematics, specifications, tolerancing, and bills of materials (BOMs).
• Knowledge of PLC, vision, reagent filling/dispensing, injection molding, drying, printing, pouching, and packaging preferred.
• Experience with automation development (batch and continuous methods).
• Good technical writing skills.
• Competent in writing and performing validations in a GMP and ISO9001 regulated environment; statistical analysis and sampling experience preferred.
• Proficiency in Solidworks or CAD.
• Familiarity with Food and Drug Administration (FDA), Good Manufacturing Practices (GMP), ISO 9000 Standards, and Occupational Safety and Health Administration (OSHA) regulations.
• Good written and verbal communication skills.
• Excellent problem solving skills are required.
• Working knowledge of MS Office.
• Good communication, organizational, and time management skills; ability to pay close attention to detail.
• Ability to work as part of a team.
• Ability to identify and correct problems.