ApiJect - Durham, NC
posted 3 days ago
About the position
ApiJect is seeking a Sr. Device Development Engineer. This role will work hybrid schedule with ability to work from home and requiring some time on-site in the Durham office. The engineer will lead design and development activities and sustaining engineering activities related to ApiJect's device technology, including, but not limited to testing, design control activities, risk management activities, and change control. Responsibilities include scoping, implementing and leading team projects/tasks, creating and maintaining design history documentation in accordance with applicable regulations and standards, providing support during regulatory inspections and customer audits, managing technical investigation teams, driving process and device improvements, developing and validating new test methods, planning and supporting human factors studies, executing statistical analysis using Minitab, and ensuring appropriate application of company policies and procedures for device development.
Responsibilities
- Leads design and development activities and sustaining engineering activities related to ApiJect's device technology.
- Responsible for scoping, implementing and leading team projects/tasks.
- Create and maintain design history documentation in accordance with applicable regulations and standards.
- Provides support during regulatory inspections and customer audits.
- Manage technical investigation teams as required by development activities.
- Drive process and device improvements through characterization, testing, design of experiments, data analysis and simulation.
- Development and validation of new test methods and characterization techniques with internal and external laboratories.
- Plan and support human factors studies.
- Execute statistical analysis using Minitab.
- Ensure appropriate application of company policies and procedures for device development, risk management, test method development, statistical data analysis, and support of regulatory filings.
Requirements
- Bachelor's degree or advanced degree in Engineering or Pharmaceutical Sciences; Masters degree is preferred.
- 5+ years of engineering experience, or equivalent with higher education, in relevant industry roles.
- 3+ years of engineering experience in medical device or pharmaceutical development.
- Exposure to Injectables and Blow Fill Seal technology operations, preferred.
- Deep understanding of the medical device regulatory environment and applicable regulations and standards.
- Knowledge of global industry standards (e.g. ISO, AAMI, ANSI, etc.).
- Experience developing and commercializing regulated devices/combination products under Design Control and ISO 14791 requirements.
- Experience providing statistically sound guidance and justifications for design changes, qualification activities, and product release.
- Driven, energetic, self-assured professional with high personal integrity.
- Able to initiate conversations to get the support/clarity necessary to carry out a task.
- Proficient in MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook).
- Demonstrated problem solving ability.
Nice-to-haves
- Experience in Injectables and Blow Fill Seal technology operations.
Benefits
- Full-Time position with a hybrid work schedule.
