Senior Manufacturing Engineer

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Location:

North Billerica, MA

The Lead Process Engineer is responsible for advancing the site’s manufacturing capabilities by developing new processes and systems and providing technical leadership across all areas of manufacturing. The role also ensures legacy product lines are continuously improved and new product lines transition smoothly into full production, all while adhering to financial and schedule commitments.

• Propose, justify, and manage large‐scale improvement projects with significant business impact involving processes, products, and equipment enhancements.
• Serve as a subject‐matter expert, staying informed of new technological developments that may affect the organization.
• Introduce relevant modern technology and methodology to manufacturing operations.
• Provide advanced technical manufacturing expertise to all levels of the organization.
• Support Lean initiatives through robust engineering and leadership on goals such as 5S, Value Stream Mapping, and Kaizen.
• Act as a lead resource for New Product Development activities, designing for manufacturability and supporting the product life cycles.
• Drive preventative maintenance process improvements and system development.
• Manage budgets and equipment purchase and installation for large‐scale or high‐impact projects.
• Execute safety, ergonomics and production risk assessments as required for business goals.
• Lead and coach others in the use of advanced Six Sigma tools to improve the quality of process outputs by identifying and removing the causes of defects and minimizing process variability.
• Collaborate with program development on new product launches and product transfers to manufacturing; develop and conduct Factory Acceptance Tests and equipment validation ensuring a high degree of process capability.
• Maintain all necessary documentation and approvals; develop standard operating procedures, work instructions, and assist with related training.
• Collaborate and partner with various departments to investigate and troubleshoot process or equipment issues, implementing corrective actions using PFMEA, root‐cause analysis, and other risk‐management methodologies.
• Oversee the development and implementation of timely, economical, repeatable, validated, mistake‐proof manufacturing processes and controls for new and legacy products.
• Perform complex analysis and problem solving throughout the workday.
• Work on a PC including repetitive use of a keyboard and mouse for long periods.
• Travel by air/car to other Meridian locations as needed.
• Carry a cell phone to facilitate intra‐department communication during and after normal business hours.

• Bachelor’s degree in a Science or Engineering field (Master’s degree preferred).
• 8–10 years of experience in manufacturing engineering, industrial engineering, process improvement, manufacturing quality, or design transfer.
• Experience in an FDA‑regulated production environment.
• Strong background in good manufacturing practices and ISO requirements.
• Experience in equipment design, maintenance, and maintenance procedure development.
• Ability to work in a fast‐paced environment with multiple priorities.
• Exemplary verbal and written communication and organizational skills.
• Ability to work independently with minimal supervision.
• Training and experience in testing and troubleshooting electromechanical assemblies.
• Familiarity with good laboratory practices.
• Demonstrated knowledge of advanced problem‐solving methods, lean, and Six Sigma tools.
• Leadership experience in design of experiments and engineering controls.
• Flexible to work longer hours and weekends as needed to meet production schedules.
• Highly organized, proficient in Solid Works; experience with AutoCAD.

Salary Range: $130,000 – $150,000

* All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*