ECI
Senior Software Engineer (Med Device Manufacturing) #7728
ECI, Irvine, California, United States, 92713
Senior Software Engineer (Med Device Manufacturing) #7728
Location: Irvine, CA
About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role We are seeking a senior‑level engineer to drive the integration and migration of in‑house software tools used for functional testing in manufacturing.
The ideal candidate will bring strong technical expertise in C# development, along with a solid understanding of medical device manufacturing processes and related software systems. This individual should be able to work independently and proactively, demonstrating ownership, problem‑solving, and collaboration skills to ensure a smooth and efficient transition across multiple applications and cross‑functional teams.
What You’ll Do
Review existing software tools for functional testing in manufacturing to determine compliance with Quality System requirements
Migrate software tools for functional testing from existing manufacturing line to new line
Work with manufacturing engineers to validate test equipment software and assist in identifying test strategies where necessary
Collaborate with cross‑functional teams, including manufacturing engineers, systems engineers, quality, R&D, and PMO
Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team
What You Will Bring
B.S or M.S. in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering or related major.
Minimum 4 years of experience in software development or testing for medical device manufacturing.
Engineering background with strong knowledge of manufacturing processes and systems.
Familiarity in C# development, particularly for manufacturing‑related applications.
Familiarity with functional testing processes within manufacturing settings.
Ability to collaborate cross‑functionally with manufacturing, quality, and R&D teams.
High ability to make knowledge‑driven decisions and work with little supervision.
Excellent documentation and communication skills for technical and process alignment.
Strong problem‑solving and analytical skills applied to production or testing workflows.
Preferred Qualifications
Experience in active implantable medical devices.
Proven ability to manage or execute software migration projects for in‑house manufacturing software tools.
Knowledge of ISO 13485 and FDA QSR.
Working knowledge of IEC 60601 and/or 62304.
Equal Opportunity & Employment Eligibility ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role We are seeking a senior‑level engineer to drive the integration and migration of in‑house software tools used for functional testing in manufacturing.
The ideal candidate will bring strong technical expertise in C# development, along with a solid understanding of medical device manufacturing processes and related software systems. This individual should be able to work independently and proactively, demonstrating ownership, problem‑solving, and collaboration skills to ensure a smooth and efficient transition across multiple applications and cross‑functional teams.
What You’ll Do
Review existing software tools for functional testing in manufacturing to determine compliance with Quality System requirements
Migrate software tools for functional testing from existing manufacturing line to new line
Work with manufacturing engineers to validate test equipment software and assist in identifying test strategies where necessary
Collaborate with cross‑functional teams, including manufacturing engineers, systems engineers, quality, R&D, and PMO
Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team
What You Will Bring
B.S or M.S. in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering or related major.
Minimum 4 years of experience in software development or testing for medical device manufacturing.
Engineering background with strong knowledge of manufacturing processes and systems.
Familiarity in C# development, particularly for manufacturing‑related applications.
Familiarity with functional testing processes within manufacturing settings.
Ability to collaborate cross‑functionally with manufacturing, quality, and R&D teams.
High ability to make knowledge‑driven decisions and work with little supervision.
Excellent documentation and communication skills for technical and process alignment.
Strong problem‑solving and analytical skills applied to production or testing workflows.
Preferred Qualifications
Experience in active implantable medical devices.
Proven ability to manage or execute software migration projects for in‑house manufacturing software tools.
Knowledge of ISO 13485 and FDA QSR.
Working knowledge of IEC 60601 and/or 62304.
Equal Opportunity & Employment Eligibility ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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