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Product Improvement Engineer

Full-time Danaher Corporation in Satellite company
  • Sunnyvale, California, USA, 94043 View on Map
  • Salary: Negotiable
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Job Description

 

 

Post: Product Improvement Engineer

Location : Sunnyvale, California

Employer: Danaher Corporation

Job type: Full- Time

Experience Range : 2-3+ Years

 

 

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

 

MINIMAL Requirements:

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

 

Physical Requirements/abilities:

  • Ability to work in an office and lab environment (BSL2 setting)
  • Occasional lifting (10-20 lbs)

 

PREFERRED REQUIREMENTS:

  • 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.

 

Job seekers Tags: Jobs in Sunnyvale California, Danaher Corporation in Near Me, Product Improvement Engineer Jobs in Near Me, Full Time Jobs

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