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Danaher Corporation Automation Development Engineer in Newark, California

POSITION SUMMARY:

Will use your experience to design and develop medical device manufacturing processes. Responsible for evaluating current capabilities, available technology in the industry, and product requirements to develop new and improve current methods and processes, drive equipment design in a large-scale environment. Will use statistical methods to develop processes and drive continuous improvement activities in collaboration with a diverse and highly talented engineering team. This is a hands-on position involving concept development, process characterization, and validation (transfer to production) Will be required to interface with cross functional teams including other engineers, scientists and operations experts. Will also be responsible for generating documents and presentations.

ESSENTIAL JOB RESPONSIBILITIES:

  • Design and perform process characterization studies and experiments using statistical methods to develop new and/or improve existing assembly processes.

  • Design, test, and validate new automation processes and/or designs in collaboration with a diverse functional engineering team.

  • Generate and sustain Verification/Validation protocols (I/OQ, PQ) and related technical documents to support the transfer of processes into Production.

  • Partner with cross functional teams to evaluate design and processes at concept phase and define manufacturing processes.

  • Develop new and/or improved processes for parts and assemblies through the application of theoretical and practical engineering.

  • Assist in failure investigations and root cause analyses as they relate to process performance.

  • Use 3D CAD modeling, CAE, statistical analysis, and hands-on bench or line testing to characterize attributes, process performance, and assembly characteristics.

TRAINING RESPONSIBILITIES:

  • Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience (in years):

  • Bachelor’s degree in field with 5+ years of related work experience OR

  • Master’s degree in field with 3+ years of related work experience OR

  • Doctoral degree in field with 0-2 years of related work experience.

Knowledge and skills:

  • Self-starting, motivated individual with proven track record of learning new skills to achieve results.

  • Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.

  • Strong data analysis skills

  • Aggressive and results oriented.

  • Data driven

  • Proven experience with DOE’s, root cause analysis, process engineering, failure investigations and automated assembly equipment.

  • Experience in process development, acceptance testing and qualification of equipment.

  • Excellent verbal and written communication skills.

  • Familiar with statistical process control methods

Physical requirements/abilities:

  • Ability to work in clean room environment.

  • Ability to use hand or power tools.

  • Ability to stoop, kneel, crawl, lift, push

PREFERRED REQUIREMENTS:

  • BS or MS in Mechanical, Biomedical Devices, Plastics Engineering (or a related field).

  • A minimum of 2+ years overall related engineering experience within medical device or a regulated industry.

  • Prior experience in biomedical device assembly process development.

  • Prior experience working with plastics.

  • Project management experience.

  • Quality Management System experience.

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) .

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