Validation Engineer

4 weeks ago


Irvine, United States Ascendum KPS Full time

ON SITE 5 DAYS A WEEK IN IRVINE, CA

Full job description

Make a meaningful difference to patients around the world. at our client's facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

How you will make an impact:

Improving manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement.

Developing basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.

Analyzing and resolving basic Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).

Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.

Establishing project plans to ensure deliverables are completed to customers expectations, using project management tools (e.g., Project Plan, Risk Analysis).

Identifying opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes.

Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work.

Mainly will inspect, measure, analyze, audit, calibrate and test the instrumentation, equipment, machines and procedures.

What youll need (Required):

  • Bachelor's Degree in Engineering or Scientific field Required

What else we look for (Preferred):

Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills

Basic understanding of statistical techniques

Previous experience working with lab/industrial equipment preferred (if applicable)

Good understanding and knowledge of principles, theories, and concepts relevant to Engineering

Good problem-solving, organizational, analytical and critical thinking skills

Good understanding of processes and equipment used in assigned work

Knowledge of and adherence to our client's Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast-paced environment

Must be able to work in a team environment, including immediate supervisor and other team members in the section or group; and may interact with vendors

Ability to build stable working relationships internally

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.


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