Senior Manufacturing Engineer - Medical Devices - Premier Global Links

Are you ready to collaborate with world-class innovators and bring cutting-edge medical research to life? Join our clients Boston Incubation Center, where we transform groundbreaking medical innovations into meaningful, life-enhancing products. We are seeking a Senior Manufacturing Engineer with a passion for excellence in manufacturing, particularly in cart systems, console operations, and electromechanical devices.

In this role, you will bridge the gap between R&D, pilot, and commercial manufacturing teams, contributing from early human use through to the commercialization of new products. Using your technical expertise, youll ensure processes are robust, scalable, and compliant, leveraging methodologies such as LEAN Six Sigma, Design for Manufacturing (DFM), and Design for Cost (DFC).

Key Responsibilities

What Youll Do

• Develop and optimize cost-effective, validated manufacturing processes for medical devices, focusing on capital and disposable devices (assembly, testing, sterilization, packaging).
• Produce production-level assembly and part drawings for components and sub-assemblies using SolidWorks.
• Incorporate DFM, Six Sigma, and LEAN principles to ensure manufacturability, reduce costs, and optimize production efficiency.
• Identify and evaluate contract manufacturing partners for quality, cost, delivery, and regulatory compliance.
• Serve as a liaison between the client and Contract Manufacturing Organizations (CMOs) to coordinate manufacturing activities.
• Validate manufacturing processes by conducting experiments, analyzing results, and developing detailed reports.
• Lead pFMEA development, process validations, and risk mitigation strategies.
• Create and maintain critical manufacturing documentation, including BOMs, work instructions, and travelers.

What Youll Deliver

• Robust, validated manufacturing processes aligned with project goals.
• Comprehensive task lists for DFM activities.
• Up-to-date, accurate BOMs, pFMEA, and work instructions.

Qualifications

Must-Have Skills

• Bachelor's degree or higher in Mechanical Engineering.
• 5+ years of medical device manufacturing experience, including at least 3 years in new product development and process validation.
• Hands-on expertise in cart systems, console operations, and electromechanical devices, with proficiency in troubleshooting and optimizing these systems.
• Advanced proficiency in SolidWorks (assemblies, tool/fixture design).
• Experience collaborating with contract manufacturers, particularly in capital equipment and catheter manufacturing.
• Strong background in DFM, Six Sigma, LEAN, cGMP, and process validation methodologies.
• Proficient in statistical software such as Minitab or JMP for process monitoring and improvement.

Nice-to-Have Skills

• Certification in LEAN and/or Six Sigma.
• Familiarity with sterilizable polymers and catheter fabrication techniques.