Medical Device Senior Manufacturing Engineer - Katalyst Healthcares & Life Sciences

• Client collaborates with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products.

• The Sr. Manufacturing Engineer will have high collaboration between R&D, Pilot, and commercial manufacturing and contribute from Early Human Use to the commercialization of new products. The Sr. Manufacturing Engineer will also ensure that design and manufacturing processes are characterized, robust, scalable, utilize best technologies, reflect standard work, are capable and compliant with Regulatory requirements, and are validated for Design Control

• Manufacturing using LEAN Six Sigma, Design for Manufacturing and Design for Cost Methodologies.

• The Sr. Advanced Manufacturing Engineer will act as a liaison between R&D, Supplier Development, Quality, and Operations team members assigned to the project

• Developed and optimized efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and packaging.

• Produce production-level assembly and part drawings for all components and sub-assemblies.

• Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency through activities like DFMA reviews and cycle time optimization.

• Proactively identify and evaluate potential contract manufacturing partners by analysing quality, cost, delivery timelines, and regulatory compliance capabilities to recommend optimal providers.

• Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites while fostering strong partnerships.

• Act as the liaison between Contract Manufacturing Organization (CMO) and Canon to coordinate manufacturing activities as directed by Management.

• Review engineering product specifications and CAD data/drawings as part of the design review process to ensure they meet industry and manufacturing standards and practices.

• Responsible for part/drawing release and the accuracy of the Bill of Materials (BOM).

• Drive the development and execution of complex experiments and tests (including writing and executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyse results, make recommendations, and develop reports.

• Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points within manufacturing.

• Deploy manufacturing risk assessment and mitigations, including hands-on and resourceful action plans.

• Developing and maintaining manufacturing work instructions, equipment instructions, and other documents that require quality management system controls.

• Coordinating technical communications between Canon and contract manufacturers, including design transfer.

• Providing technical expertise in conducting pFMEA and developing process validations.

• Sharing expertise in Lean Six Sigma process excellence principles.

• Collaborating with cross-functional product development teams, including project managers, optical engineers, mechanical engineers, electrical engineers, software engineers, quality engineers, regulatory specialists, clinical specialists, marketers, buyers, and others.

• Development and maintenance of project task list for DFM Activities.

• Create and maintain up-to-date BOMs, work instructions, and travellers.

• Creation and maintenance of pFMEA.

Requirements:

• Education: bachelor's degree or higher in Mechanical engineering.

• 5+ years of experience in medical device manufacturing engineering, including at least three years in new product development, design transfer to production, and validating processes.

• Excellent modelling and drawing skills using SolidWorks, including proficiency with assemblies that contain dozens of parts.

• Experience working with contract manufacturers/vendors for capital equipment, electronics testing, and/or catheter manufacturing is strongly preferred.

• Proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques.

• Technical expertise in DFM, Six Sigma, LEAN, cGMP, and process validation.

• Proficient in SolidWorks with experience in tool and fixture design.

• Highly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP for process monitoring and improvement.

• Lean and/or Six Sigma certifications preferred.