Staff Manufacturing Software Engineer

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Job description

Job Summary

As a Staff Manufacturing Software Engineer, you'll be responsible for governing the software development lifecycle (SDLC) for a wide array of measurement and automated system software projects in support of ingestible sensor manufacturing. The role will require you to lead a cross-functional team to develop instrument control and measurement software, as well as data analytics and visualization applications. You will also be expected to contribute as a team-member by coding data-parsing modules, writing database queries, or developing application programming interfaces.

In this role you'll be expected to gather requirements from stakeholders, select the appropriate technologies, come up with a robust overall software design, and develop a software solution meeting these requirements. Your solutions are expected to be performant, reliable, and in compliance with the SDLC, with a code base that is well organized and documented.

The Staff Manufacturing Software Engineer is a senior position that also requires responsibility above and beyond SDLC governance. As such, you'll be expected to represent our group in collaborative process and engineering meetings. You'll also act as a technical liaison between various interrelated departments such as IT, Operations Engineering, and Data Analytics. Finally, you may be looked upon to give guidance to junior engineers and/or oversee the work of subcontractors who are contributing to group projects.

Job Description

• Design, develop, test, and validate software for customized test measurement systems supporting Otsuka's ingestible sensor production, ensuring data integrity, user interface, and calibration needs are adequately addressed.
• Execute the full software development lifecycle (SDLC) and adhere to change control guidance according to department procedures and FDA 21 CFR part 820 requirements
• Drive projects for technical initiatives which require software solutions, writing code that is organized, easy to maintain, and well documented
• Create software solutions which are performant, scalable, reliable, and user friendly
• Evaluate and implement production informatics systems such as SPC controls, MES, MRP/ERP
• Maintain legacy systems with bug fixes and enhancements
• Work iteratively to improve the execution speed and reliability of solutions under your control
• Facilitate requirements-gathering process and produce requirements documentation
• Evaluate commercial off-the-shelf solutions for suitability in lieu of custom-developed solutions
• Advise other departments on best practices for sub-system communication

Qualifications

Required

• Integrity and patience needed to ensure all regulatory requirements are met each and every time; and the sense of responsibility to highlight and alert management when these requirements are not met
• Experience National Instruments Measurement Studio or LabView integrated with C#
• Familiar with NI data acquisition with NI-DAQmx data acquisition driver
• Knowledge of programming languages: Primary: C#, Python. Secondary: C/C++, Java
• Experience with .NET Framework, ASP.NET or Flask with Angular.
• Knowledge and experience with Asynchronous programming and multi-threading in C#
• Experience in MVVM (Model-View-ViewModel) design pattern specifically with WPF
• Experience with Rest API design and implementation
• Experience with relational database design, Microsoft SQL Server or MySQL.
• Basic understanding of statistics and data analysis; familiarity with statistical visualization software: JMP/Spotfire
• Knowledge of Dependency Injection and Dependency Inversion Principle
• Highly motivated, detail oriented, excellent communication skills

Education / Experience

• B.S. in Computer Science, Controls Engineering, or related engineering field
• 10+ years software development in measurement, controls, or automated systems
• 5+ years software development in a regulated environment (Medical Device, Pharmaceuticals, etc.)

Preferred

• Experience with support of deployed test systems in high-volume manufacturing
• Agile / Scrum project management experience

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Come discover more about Otsuka and our benefit offerings; .

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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