Job Description

Location: Woburn, MA

Vaxess is developing a pipeline of next-generation vaccines and therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the self-applied patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. 

The Senior Mechanical Engineer is a hands-on position involving designing, building, and maintaining automated production equipment throughout its lifecycle. This role will be responsible for design, assembly, installation, qualification, ongoing maintenance, and optimization of automated production systems requiring expert troubleshooting of mechanical assemblies and systems, performing root cause analysis, and implementing corrective actions to ensure efficient, reliable manufacturing operations. 

Working at Vaxess is cross-disciplinary, integrating chemistry, biology, immunology, mechanical, biomedical, and chemical engineering to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated individual to join our team. This is a unique opportunity to be part of an emerging startup and significantly influence the strategic growth and future direction of the company as we bring innovative technology to the global vaccine and therapeutic market.

Responsibilities

• Design, implement, and maintain novel automated systems and solutions that contribute to current manufacturing and scale up of manufacturing operations to eventual commercialization.
• Manage external vendors to develop plans, evaluate proposals, and ensure delivery of projects in-scope, within budget, and on time.
• Document equipment and procedures though User Requirements Specifications, detailed mechanical, electrical, and assembly drawings, and use and maintenance SOPs. Contribute to the implementation and maintenance of the Quality Management System.
• Collaborate closely with cross-functional teams to support product development and manufacturing activities, and to identify and resolve manufacturing issues. 
• Contribute to continuous improvement to increase safety, quality, and efficiency of manufacturing.

Qualifications

• BS or advanced degree in Mechanical Engineering or a related discipline. 
• At least 10 years of experience in designing, building, installing, qualifying, and maintaining automated systems for high volume medical device manufacturing. 
• Experience writing and executing IQ, OQ and PQ protocols.
• Experience developing URS, FAT and SAT documents for automated equipment
• 3D CAD (SolidWorks or similar) as well as Mechanical design of fixtures, assemblies and equipment. 
• Understanding and working knowledge of mechanical linkages, power transmissions and practices. 
• Understanding of diverse fabrication techniques, manufacturing processes, and Design for Manufacturability 
• Excellent time and project management skills and proven ability to meet goals and deadlines.
• Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams.
• Entrepreneurial spirit and drive to positively impact global human health.

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