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.

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