Danaher Corporation Product Improvement Engineer in Sunnyvale, California
ESSENTIAL JOB RESPONSIBILITIES :
In depth understanding and experience with consumables/process change qualification and implementation/documentation.
Writing verification and validation protocols.
Engage in risk analysis/assessment for improvement/sustaining projects or consumables qualifications
Follow and observe all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility.
Assist in failure investigations and root cause analyses as they relate to assay or parts/consumables qualification.
Partner effectively with functional representatives from Regulatory, Production, Quality, and other relevant departments.
Have demonstrated biology laboratory skills, including pipetting.
Have demonstrated engineering laboratory skills.
Have knowledge and experience in design control processes, experimental design, and data analysis.
Support evaluation of potential mitigations and corrective actions
Contribute to final report for each project
TRAINING RESPONSIBILITIES: (REQUIRED)
Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
Bachelor’s degree with 2-4 years of related work experience OR
Master’s degree in field with 0-2 years of related work experience.
Knowledge and skills:
Must have experience with automation lines and developing process documentation or study plans.
Experience with failure investigations and root cause failure analysis.
Proficiency with Microsoft Office Suite.
Excellent communication, writing, and documentation skills.
Ability to handle multiple projects simultaneously.
Ability to work independently and in a team setting; able to work cross-functionally.
Basic statistical skills
P hysical Requirements/abilities:
Ability to work in an office and lab environment (BSL2 setting)
Occasional lifting (10-20 lbs)
Industry experience in high volume manufacturing in medical device consumables.
Experience working on the development of diagnostic devices under design control processes is highly desirable.
Experience working with biological samples in a medical device development environment is a plus.
Knowledge of real-time Polymerase Chain Reaction (rt-PCR) or other biological applications of fluorescence-based techniques is a plus.
Experience in clean room or biosafety environment with controlled gowning procedures.
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) .