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.