Principal Software Applications Engineer Onsite in Burlington MA
About The Position
The Principal Software Applications Engineer is responsible for the design, development, and continuous improvement of systems and processes that support high-quality medical device and pharmaceutical production. This role involves cross-functional collaboration to ensure that products meet safety, regulatory, and performance standards from concept through commercialization. Key responsibilities include performing risk assessments, supporting validation and verification activities, troubleshooting manufacturing issues, and contributing to design transfer documentation. Strong knowledge of FDA regulations, ISO standards, and GMP guidelines is essential for success in this role.
Requirements
- Strong knowledge of FDA regulations.
- Strong knowledge of ISO standards.
- Strong knowledge of GMP guidelines.
Responsibilities
- Design, development, and continuous improvement of systems and processes for medical device and pharmaceutical production.
- Cross-functional collaboration to ensure products meet safety, regulatory, and performance standards.
- Performing risk assessments.
- Supporting validation and verification activities.
- Troubleshooting manufacturing issues.
- Contributing to design transfer documentation.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
No Education Listed
