Our medical device client located in the Waltham, MA area is growing and looking to add a Lead / Principal Automation Engineer to their combination device engineering team! This will be a hands-on lab based role with opportunity to help build and lead a small team! Lead Engineer will support the automated manufacturing equipment and have the opportunity to build manufacturing capacity from the ground up to bring innovative technology to the global markets! Responsibilities include but not limited to:
Build and lead a team of engineers to prototype and develop automated manufacturing and inspection equipment to increase throughput and scale of the company's intradermal patch manufacturing from pilot through commercial scales.
Devise robust and scalable tools, fixtures, and process aids to improve quality and throughput of manufacturing operations.
Manage development of imaging systems and machine vision programs for in-process and finished product inspections.
Manage new equipment procurement projects by interfacing with outside vendors, developing engineering specifications, and drafting and reviewing qualification protocols.
Author equipment operation and maintenance SOPs and other controlled documents within the Quality System
Manage, train, supervise, and mentor junior members of the engineering team.
Collaborate closely with cross-functional teams to support product development and manufacturing activities.
Requirements:
10 years' industry experience minimum in medical device or pharmaceutical environments , minimum BS in Mechanical, Industrial, , or other relevant engineering discipline
Demonstrated ability to effectively manage a small team of junior engineers; proven project and time management skills and ability to efficiently achieve goals within timelines
Prior experience developing automated systems with machine vision, PLCs, and robotics is required. Exceptional candidates will have experience with automated liquid handling or 3d printing techniques, deep/machine learning, ideally in medical device or pharmaceutical environments
Proficient with: Solidworks or similar 3D CAD software; ATS SmartVision, Cognex VisionPro, or other machine vison software
Knowledge of GxP requirements and experience working within a medical device or pharmaceutical quality system