Danaher Corporation Process Engineer in Sunnyvale, California
ESSENTIAL JOB RESPONSIBILITIES:
Responsible for performing process qualifications for new and existing production lines.
Follow and observe all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility.
Assist in creating and updating manufacturing SOPs/Work Instructions.
Provide training to Manufacturing personnel.
Recognize machine operating conditions and requirements for optimum production runs and can troubleshoot and resolve basic line performance issues.
Effectively interface with other engineering disciplines, such as Controls & Automation engineering and New Product Introduction teams.
Develop and deliver oral and written communications around qualification projects.
Organize an analytical approach to problem solving with familiarity with FDA and GMP.
Partner effectively during root cause investigation through resolution with functional representatives of regulatory, automation, molding/tooling, production and quality.
Coordinate engineering testing and qualification activities for validation and verification of consumables components.
Maintain and/or improve existing consumables parts production, with an emphasis on improving manufacturability, achieving cost reductions, and enhancing throughput.
Actively participate in group meetings and be a technical point person in project teams.
Hands-on participation in failure analyses, validations, parts design, and test method development
Assist in failure investigations and root cause analyses as they relate to consumables part performance in high speed automation environments.
- 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:
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
Demonstrated experience designing, coordinating, executing, and documenting complex product and/or process validations and qualifications
Experience with failure investigations and root cause failure analysis
Ability to work cross-functionally and drive consensus
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) .