Senior Manufacturing Engineer

4 weeks ago

Cambridge, Massachusetts, United States KLM Careers Full time
Job Description

The Senior Manufacturing Engineer will play a key role in the development and commercialization of new medical devices. This individual will collaborate closely with R&D, Pilot, and commercial manufacturing teams to ensure design and manufacturing processes are robust, scalable, and compliant with regulatory requirements.

Key Responsibilities:

  • Develop and optimize efficient, cost-effective, and validated manufacturing processes for medical devices.
  • Produce production-level assembly and part drawings for all components and subassemblies.
  • Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs.
  • Proactively identify and evaluate potential contract manufacturing partners.
  • Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites.
  • Act as the liaison between Contract Manufacturing Organization (CMO) and Canon to coordinate manufacturing activities.
  • Review engineering product specifications and CAD data/drawings to ensure they meet industry and manufacturing standards.
  • Responsible for part/drawing release and the accuracy of the Bill of Materials (BOM).
  • Drive the development and execution of complex experiments and tests to qualify and validate manufacturing processes.
  • Responsible for Characterization and Validation activities, including CTQ flowdown and identification of critical control points within manufacturing.
  • Deploy manufacturing risk assessment and mitigations.
  • Develop and maintain manufacturing work instructions, equipment instructions, and other documents that require quality management system controls.
  • Coordinate technical communications between Canon and contract manufacturers, including design transfer.
  • Provide technical expertise in conducting pFMEA and developing process validations.
  • Share expertise in Lean Six Sigma process excellence principles.
  • Collaborate 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.

Requirements:

  • 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.
  • Experience working with cart systems, console operations, and electromechanical devices, including handson experience in troubleshooting, maintaining, and optimizing these systems in a mechanical and electrical integration environment.
  • Excellent modeling 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.

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