Medical Device Manufacturing Engineer

4 weeks ago

Cambridge, Massachusetts, United States MetaOption LLC Full time
Job Title: Medical Device Senior Manufacturing Engineer

MetaOption LLC is seeking a highly skilled Medical Device Senior Manufacturing Engineer to join our team. As a key member of our manufacturing team, you will be responsible for developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices.

Key Responsibilities:
  • Develop and optimize manufacturing processes for medical 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.
  • Proactively identify and evaluate potential contract manufacturing partners by analyzing quality, cost, delivery timelines, and regulatory compliance capabilities.
  • 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 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 on new or existing product lines to qualify and validate manufacturing processes.
  • 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.
  • Develop and maintain manufacturing work instructions, equipment instructions, and other documents that require quality management system controls.
  • Coordinate technical communications between company 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.
Qualifications:
  • 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 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.
Nice to Haves:
  • Lean and/or Six Sigma certifications preferred.

MetaOption LLC is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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