Senior Manufacturing Process Engineer

Senior Manufacturing Process Engineer Job Description Template

Our company is looking for a Senior Manufacturing Process Engineer to join our team.

Responsibilities:

  • Manage design, implementation, system integration, verification, and validation of devices in various test platforms;
  • Take ownership of all manufacturing processes and equipment. Troubleshoot and find solutions to problems;
  • Provide new ideas for process improvements, design new fixtures and optimize automation process. Test ideas and provide results in a timely fashion;
  • Create MES life-cycle strategy for change management;
  • Trouble shooting daily operational issues to define root cause, working in collaboration with Manufacturing and Quality;
  • Communicate system integration information to management;
  • Take charge of the transfer of new products from R&D to commercial manufacturing;
  • SPOC for MES and collaborate with IT, Manufacturing, Quality, Supply Chain & Process Development to drive continuous improvements using MES;
  • Administrate and maintain site MES system;
  • Present findings based on process data taken from the manufacturing team;
  • Designs jigs, guards, and fixtures to aid associates;
  • Provide training to associates;
  • Provides direction for development, maintenance, and procedures;
  • Actively maintain knowledge of new technologies, methods and techniques;
  • Lead Kaizen events and sustain results using DBS tools.

Requirements:

  • Demonstrated ability to understand and successfully work across multiple disciplines such as engineering, software and manufacturing highly desired;
  • Leadership skills, including ability to organize, clarify and influence others;
  • Must have made substantial contributions to the technical sections of registration filings and post-approval inspections;
  • 5 to 10 years experience in successful, commercial product development;
  • Injection molding knowledge is a plus. Process tooling experience optional. Hands-on machining experience optional;
  • Proficiency in Windows based MS Word, MS Excel, MS Access and experience with CAD and statistical analysis programs such as SolidWorks;
  • Must have managed the technical components of a late stage medical device project, from phase 3 clinical supply through commercial scale-up;
  • A solid understanding of US and EU regulatory requirements for medical devices is necessary. Familiarity with ISO requirements;
  • Experience of supervising and collaborating with engineers, scientists and research assistants;
  • Working knowledge of basic test equipment (DVM, Oscilloscope, etc) and calibration standards;
  • English and Chinese bilingual skill is a plus;
  • Ability to communicate with widely varied audiences;
  • Presentation skills;
  • Mechanical aptitude;
  • Analytical skills – advanced skills in Excel, Access, and VBA.