SENIOR MANUFACTURING ENGINEER

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 Work with product development staff to ensure that products under development are optimally manufacturable that may include but not be limited to mechanical assembly/dimensioning/tolerances, electrical wiring, materials selection and fabrication methods
Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero-defect level as well as low product cost
Installation of Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), and DOEs
Write manufacturing procedures
Investigate benefits and features of capital equipment and generate capital appropriation justifications
Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions
Provide engineering support to production department in troubleshooting and resolving technical problems
Coordinate work with outside vendors
Plan and schedule projects in a manner consistent with corporate objectives
Provide on-site technical support during project activities such as scale-up, equipment transfer, process validation and process optimization.
Support prototype and pilot production of new products, product changes, and enhancements in coordination with the R&D, Manufacturing and Quality Control functions
Supervise the complete, accurate, and timely preventive maintenance of equipment and tooling
Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
Ensure that all regulatory and internal policies are followed


DESIRED SKILLS AND EXPERIENCE:
Requires a minimum of 5 years related experience
Requires a Bachelor/Masters degree or equivalent in engineering or related discipline
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
May determine methods and procedures on new assignments and may provide guidance to other personnel
Must be competent with Word, Excel, Project, Power Point applications
Experience with Design of Experiments and statistical analysis packages
Six Sigma, Black Belt Certification is a strong plus