We are looking for a Manufacturing Engineer to join our client in Cambridge, Ma on a direct hire basis.
The Manufacturing Engineer will support manufacturing of the cartridge (primary package container for pharmaceutical drug) at our contract manufacturer as well as development and testing of the primary package container at the office. They will have the opportunity to work in a fast-paced start-up environment that values intellectual rigor, teamwork, and commitment.
Role and Responsibilities
- Manage manufacturing activities at contract manufacturer
- Plan DOEs, own the cartridge design verification plan, write test plans and protocols, and assist with testing
- Develop and implement equipment improvements, validation, and documentation
- Analyze process data, provide technical troubleshooting/problem solving, and lead quality and continuous improvement projects
- Participate in risk management processes
- Work independently and within a team of product development engineers, quality engineers, and operations.
Required Skills and Experience
- BS in an engineering discipline such as mechanical or biomedical
- 3-8 years of experience with medical devices
- Experience with ISO 13485 compliant quality management systems
- Primary packaging experience is strongly preferred
- Pharmaceutical experience is preferred
- Experience with statistical techniques and data analysis tools such as Minitab
- Willing to travel internationally up to 30%