Manufacturing Engineer II​/III

Role Summary

Manufacturing Engineer II/III based in Northbridge, MA. Responsible for process sustaining and improvement of all component, device, and packaging related projects. Requires the application of continuous improvement, equipment oversight, trending, layout planning, testing, data analysis and report writing to resolve and improve manufacturing efficiencies. Collaboration with internal R&D, Quality, Regulatory and Operations, as well as external vendors, to meet project timelines and maintain process sustaining activities.

• Ability to identify and lead engineering related projects to continuously review and revise processes in production to enhance quality, yield, and efficiency.
• Author and execute equipment commissioning and qualification protocols and reports.
• Apply lean manufacturing methodologies to reduce costs and increase efficiency.
• Oversee production operations and troubleshoot technical issues in cleanroom environments.
• Coordinate and communicate engineering related activities with product vendors and suppliers.
• Support the design, development, and optimization of processes, including upstream and downstream operations.
• Troubleshoot process-related issues and lead quality investigations and implementation of corrective actions.
• Create, customize and implement tooling and fixturing to increase efficiency and product quality in manufacturing.
• Generate and maintain process documentation, including standard operating procedures, work instructions, and batch records.
• Work in cross-functional teams and with other departments to implement changes.
• Serve as subject matter expert from the functional area.
• Ensure compliance with GMP and regulatory standards.

• Strong mathematical and statistical abilities to gather data and calculate optimal output.
• Proficiency with equipment, facility, and process validations.
• Analytical skills to analyze process steps and seek optimization.
• Mechanical skills to oversee the use of equipment used in production.
• Familiarity with engineering software like AutoCAD and SOLIDWORKS.
• Proficient in Microsoft Applications (Word, Excel, PowerPoint, Visio).
• Strong commitment to compliance and ethical standards.
• Proficiency with cGMP regulations and quality management systems.

• Project management and cross-functional collaboration
• Process analysis and problem solving
• Documentation and record-keeping (SOPs, work instructions, batch records)
• Tooling and fixturing design and implementation
• Equipment commissioning and qualification
• Lean manufacturing and waste reduction

• Bachelor of Science
• Preferred Field of Study:
  Engineering

• 3–5 years of experience in the medical device and/or pharmaceuticals industry.
• Proactive and creative problem solver who is highly organized and detail oriented.
• Strong listening and communication skills—both written and verbal.
• Ability to contribute to development of project timelines and meet deadlines.
• Adaptability, resiliency, and ability to thrive in a fast-paced organization.
• Ability to influence and drive organizational success.
• Exceptional project management skills; proficiency in tracking processes and projects.
• Willingness to collaborate cross-functionally and build relationships on projects of diverse scope.
• Ability to lift up to 25 pounds on occasion.