Danaher Corporation Process Engineer in Suzhou, China
The Process Engineer is responsible for developing a strategy and executing plan to deliver process performance improvements related to Safety, Quality, Delivery, and Cost of a manufacturing process or line. Process Engineer will help execute change management plan, and execution plan to improve flow of products. The Process Engineer will also leverage process knowledge to identify opportunities / solutions to improve throughput capacity by reducing impact of constraints.
ESSENTIAL JOB RESPONSIBILITIES:
Responsible for performing process qualifications for new and existing production lines.
Follow and observe all regulatory requirements (cGMP’s, ISO, NMPA, internal policies) applicable to area of responsibility.
Apply knowledge of relevant continuous improvement tools and approaches to increase production up-time, minimize unplanned maintenance, minimize work in process inventories (WIP) or plant inventories, and implement cost reduction initiatives across equipment and labor.
Assist in creating and updating manufacturing SOPs/Work Instructions.
Provide training to Manufacturing personnel.
Seek and implement process improvements within Manufacturing.
Recognize machine operating conditions and requirements for optimum production runs and can troubleshoot and resolve basic line performance issues.
Identify constraints in, or non-conformances resulting from, the production process through analysis of material, people and information movement/flow.
Effectively interface with other engineering disciplines, such as Controls & Automation engineering and New Product Introduction teams.
Develop and deliver oral and written communications around process improvement projects.
Organize an analytical approach to problem solving with familiarity with NMPA and cGMP.
Work within operating procedures to identify, change, justify, and implement process improvements to process capability, equipment availability, and yield improvement.
Utilize and leverage ongoing data and convert information into actionable procedures and reaction/escalation plans aligned with maintaining validated state of Class II and Class III automated equipment.
Develop validation documentation for line extensions and process improvements and is the manufacturing liaison for all process qualifications.
Partner effectively during root cause investigation through resolution with functional representatives of regulatory, automation, molding/tooling, production and quality.
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
Bachelor’s degree in Engineering/related discipline or equivalent combination of education and experience to perform at this level
A minimum of 2-4 years overall related business experience in Manufacturing preferably in medical device
Knowledge and skills:
Excellent written and oral communications skills in both English and Chinese
Experience with Lean and Six Sigma
The ideal candidate should have experience with automation lines and developing process documentation.
Must be able to work collaboratively in a matrix environment to implement solutions addressing problems associated with commercial production.
In depth understanding of production and quality control techniques (such as CFM and TQM).
Understanding of financial processes (standard cost development) and business planning.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .