Position: Manufacturing Engineer
Location: Massachusetts (100% Onsite)
Overview
We are looking for Manufacturing Engineers to support the installation, commissioning, and qualification of new manufacturing equipment for a newly established production line. This is a hands-on, onsite role focused on bringing new equipment from installation through IQ (Installation Qualification) to support a critical product launch.
The ideal candidate will have strong experience in regulated medical device manufacturing environments and be comfortable working cross-functionally with quality, validation, and commissioning teams.
Key Responsibilities
- Lead and support the installation and commissioning of new manufacturing equipment.
- Partner with Quality, Validation, and Engineering teams to transition equipment from installation through the IQ phase.
- Develop and author User Requirement Specifications (URS).
- Create and execute Installation Qualification (IQ) protocols.
- Perform onsite qualification activities and ensure compliance with regulatory standards.
- Troubleshoot equipment issues during commissioning and qualification phases.
- Support documentation in accordance with FDA and GMP requirements.
- Contribute to the successful launch of a new production line.
- Collaborate with vendors and internal stakeholders to ensure equipment meets performance and regulatory expectations.
Required Qualifications
- Hands-on experience with installation, commissioning, and qualification of manufacturing equipment.
- Proven ability to author and execute URS and IQ protocols.
- Prior experience in a Medical Device manufacturing environment.
- Strong understanding of GMP and regulatory documentation standards.
- Ability to work independently in a fast-paced, onsite setting.
