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
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
- 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.
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