Duration-
6-12 Month Contract (12 months expected)
Position Overview:
Manufacturing Engineer NPI to support Test Method Validation (TMV), doing Process Validation, and doing the Documentation for the Test Processes associated with Robotic Assembly.
Details:
- Work closely with the Manufacturing and Design teams to design, develop, document, and qualify manufacturing and test processes used during the manufacturing of electro-mechanical components and subassemblies of medical robotic systems. Support production floor with training and troubleshooting activities.
- Duties Perform Process Validations as required, IQ/OQ/PQ; generate Protocols and Test Reports, Documentation etc.
What’s needed:
- Manufacturing Engineer Experience with Quality-based documentation in support of validation/ TMV would be ideal. Basic experience with CAD packages, and basic software skills (understanding of Linux, and basic understanding of scripting languages.)
- The Manufacturing Engineer NPI is responsible for acting with high drive and urgency to launch products to market as an individual contributor, on a cross functional team, conducting various assignments in cooperation with direction of team & team leader. Scope of responsibility included specifying, procuring, qualifying, validating, troubleshooting, and maintaining test equipment and test procedures needed for robotic assembly and test, dispensing, and/or packaging components and/or products. Supports investigations to determine root cause of failures, presents results, and proposes corrective and preventative actions as required. Uses capabilities, such as Lean/Six Sigma, DFx, SPC, etc, to improve company knowledge, products and processes. Collaborates and interacts with other company engineering teams, including teams representing R&D, Product Quality, Regulatory, and Supplier Quality. Provide engineering, risk assessment, and statistics support in the development and maintenance of the company’s quality systems. Follows domestic and international regulatory standards (e.g., GMP and ISO 13485).
In This Role You Will
- Work closely with the Manufacturing and Design teams to design, develop, document, and qualify manufacturing and test processes used during the manufacturing of electro-mechanical components and subassemblies of medical robotic systems
- Support production floor with training and troubleshooting activities
- Develop process windows/limits for manual and automated production processes.
- Design, develop, document, and qualify electro-mechanical manufacturing fixtures utilizing both custom and off-the shelf hardware and software
- Perform process validations as required, IQ/OQ/PQ; generate protocols and test reports
- Authors and reviews technical protocols, reports, standards and change orders.
- Assist in the development of test algorithms, test scripts, data acquisition and measurement systems with focus on repeatability and reproducibility
- Automate test processes utilizing in-house developed test software and scripts
- Understands and applies test methods to locate, reproduce, identify, and analyze complex failures. Develop Process Failure Mode and Effects Analyses
- Apply comprehensive & diverse knowledge of engineering principles to assignments.
- Participates in presentation of progress and results to all levels of organization.
Qualifications:
- A minimum of a Bachelor’s degree in Electrical Engineering, Mechanical Engineer or related engineering field is required
- A minimum of 4-6 years of experience in a technical field required
- Produce high quality documentation that is clearly understandable by internal and external personnel is required
- Basic understanding and experience of electrical systems and is required
- Ability to read engineering drawings and schematics is required
- Proficiency and knowledge with electrical test equipment such as multimeters, oscilloscopes, and power supplies is required
- Experience in Product Lifecycle Management systems such as Oracle Agile is highly preferred
- Experience in Medical Device industry and/or manufacturing engineering is preferred
- Experience with Process Validation (IQ/OQ/PQ), able to generate protocols and test reports
- Experience working on instrumentation automation and using scripting languages such as Python, Shell, Batch, Bash or Linux commands is preferred
- Knowledge of LEAN/ Six Sigma and Process Six Sigma is preferred.
- Ability to travel up to 10% to contract manufacturers is required
Santa Carla CA: Manufacturing Engineer NPI (233799)
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